Trial Outcomes & Findings for A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa (NCT NCT00447980)

Last Updated: 2025-05-01

Results Overview

The primary efficacy endpoint was the change in Humphrey VFS from baseline to month 12 (Visit 10) as determined by the HVF 30-2 test, comprised of 76 points. The measure was the sum of actual thresholds for all 76 locations.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-01

Participant Flow

A total of 90 participants were screened and 73 were randomized to dose groups. 17 of 90 patients were screen failures and not associated (randomized) to either arm. Of the 73 randomized participants, 5 participants, 2 in the high dose and 3 in the low dose arms were randomized but did not receive surgery and did not take part in the study. 68 participants had surgery. For participants randomized to treatment dose, one eye was randomized to surgery and the fellow eye was randomized to sham.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Participants That Received Low Dose NT-501 Implant Surgery and Sham Surgery in Fellow Eye NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Surgery in Fellow Eye	Sham Treatment in Fellow Eye for Low Dose Arm Sham Surgery in Fellow Eye for NT-501 Low Dose Implant Arm	Participants That Received High Dose NT-501 Implant Surgery and Sham Surgery in Fellow Eye NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Surgery in Fellow Eye	Sham Treatment in Fellow Eye for High Dose Implant Arm Sham Surgery in Fellow Eye for NT-501 Low Dose Implant Arm
Overall Study STARTED	23 23	23 23	50 50	50 50
Overall Study NT-501 Surgery Completed	20 20	20 20	48 48	48 48
Overall Study COMPLETED	18 18	18 18	44 44	44 44
Overall Study NOT COMPLETED	5 5	5 5	6 6	6 6

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants That Received Low Dose NT-501 Implant Surgery and Sham Surgery in Fellow Eye NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Surgery in Fellow Eye	Sham Treatment in Fellow Eye for Low Dose Arm Sham Surgery in Fellow Eye for NT-501 Low Dose Implant Arm	Participants That Received High Dose NT-501 Implant Surgery and Sham Surgery in Fellow Eye NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Surgery in Fellow Eye	Sham Treatment in Fellow Eye for High Dose Implant Arm Sham Surgery in Fellow Eye for NT-501 Low Dose Implant Arm
Overall Study Withdrawal by Subject	1	1	4	4
Overall Study Lost to Follow-up	1	1	0	0
Overall Study Did not proceed with surgery	3	3	2	2

Baseline Characteristics

MITT Population who received an implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose - Implant n=23 Eyes NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	Low Dose - Sham n=23 Eyes Sham Implant in Fellow Eye (Low Dose Arm)	High Dose - Implant n=50 Eyes NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	High Dose - Sham n=50 Eyes Sham Implant in Fellow Eye (High Dose Arm)	Total n=146 Eyes Total of all reporting groups
Age, Continuous	34.9 Years STANDARD_DEVIATION 12.0 • n=23 Participants	34.9 Years STANDARD_DEVIATION 12.0 • n=23 Participants	40.2 Years STANDARD_DEVIATION 11.8 • n=50 Participants	40.2 Years STANDARD_DEVIATION 11.8 • n=50 Participants	37.6 Years STANDARD_DEVIATION 11.9 • n=73 Participants
Sex: Female, Male Female	11 Participants n=23 Participants	11 Participants n=23 Participants	26 Participants n=50 Participants	26 Participants n=50 Participants	74 Participants n=73 Participants
Sex: Female, Male Male	12 Participants n=23 Participants	12 Participants n=23 Participants	24 Participants n=50 Participants	24 Participants n=50 Participants	72 Participants n=73 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=23 Participants	1 Participants n=23 Participants	4 Participants n=50 Participants	4 Participants n=50 Participants	10 Participants n=73 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=23 Participants	22 Participants n=23 Participants	46 Participants n=50 Participants	46 Participants n=50 Participants	136 Participants n=73 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=73 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=23 Participants	1 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	2 Participants n=73 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants	1 Participants n=23 Participants	1 Participants n=50 Participants	1 Participants n=50 Participants	4 Participants n=73 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Black or African American	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=73 Participants
Race (NIH/OMB) White	21 Participants n=23 Participants	21 Participants n=23 Participants	49 Participants n=50 Participants	49 Participants n=50 Participants	140 Participants n=73 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=73 Participants
Ocular History - Years Since RP Diagnosis	8.85 years STANDARD_DEVIATION 8.39 • n=23 Participants	8.85 years STANDARD_DEVIATION 8.39 • n=23 Participants	10.49 years STANDARD_DEVIATION 9.86 • n=50 Participants	10.49 years STANDARD_DEVIATION 9.86 • n=50 Participants	10.00 years STANDARD_DEVIATION 9.41 • n=73 Participants
Type of Ocular History Ocular disease	23 Eyes n=23 Eyes	23 Eyes n=23 Eyes	50 Eyes n=50 Eyes	50 Eyes n=50 Eyes	146 Eyes n=146 Eyes
Type of Ocular History Ocular surgery	3 Eyes n=23 Eyes	3 Eyes n=23 Eyes	10 Eyes n=50 Eyes	11 Eyes n=50 Eyes	27 Eyes n=146 Eyes
Type of Ocular History Ocular treatment	0 Eyes n=23 Eyes	0 Eyes n=23 Eyes	2 Eyes n=50 Eyes	4 Eyes n=50 Eyes	6 Eyes n=146 Eyes
Humphrey Visual Fields - Total Sensitivity (MITT Population)	1142.4 dB STANDARD_DEVIATION 446.33 • n=20 Participants • MITT Population who received an implant	1135.9 dB STANDARD_DEVIATION 423.50 • n=20 Participants • MITT Population who received an implant	969.8 dB STANDARD_DEVIATION 391.74 • n=48 Participants • MITT Population who received an implant	961.7 dB STANDARD_DEVIATION 435.68 • n=48 Participants • MITT Population who received an implant	1052.5 dB STANDARD_DEVIATION 424.31 • n=68 Participants • MITT Population who received an implant

PRIMARY outcome

Timeframe: 12 months

Population: MITT Population excluding 1 participant from the high dose arm who did not complete any visits subsequent to surgery.

Outcome measures

Outcome measures
Measure	Low Dose - Implant n=20 Participants NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	Low Dose - Sham n=20 Participants Sham Implant in Fellow Eye (Low Dose Arm)	High Dose - Implant n=47 Participants NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	High Dose - Sham n=47 Participants Sham Implant in Fellow Eye (High Dose Arm)
Change in Humphrey Visual Fields - Total Sensitivity	1.4 dB Standard Deviation 174.58	16.8 dB Standard Deviation 165.41	-164.8 dB Standard Deviation 115.02	-66.7 dB Standard Deviation 103.23

SECONDARY outcome

Timeframe: Baseline compared to 6, 12, 18, 24 and 30 months

Population: MITT Population excluding 1 participant from the high dose arm who did not complete any visits subsequent to surgery.

Outcome measures

Outcome measures
Measure	Low Dose - Implant n=20 Participants NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	Low Dose - Sham n=20 Participants Sham Implant in Fellow Eye (Low Dose Arm)	High Dose - Implant n=47 Participants NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	High Dose - Sham n=47 Participants Sham Implant in Fellow Eye (High Dose Arm)
Change in Mean Humphrey Visual Fields Sensitivity 6 Months - Change from BL	-1.21 dB Standard Deviation 140.09	25.80 dB Standard Deviation 128.34	-135.23 dB Standard Deviation 107.86	-42.99 dB Standard Deviation 82.85
Change in Mean Humphrey Visual Fields Sensitivity 12 Months - Change from BL	1.35 dB Standard Deviation 174.58	16.75 dB Standard Deviation 165.41	-164.79 dB Standard Deviation 115.02	-66.65 dB Standard Deviation 103.23
Change in Mean Humphrey Visual Fields Sensitivity 18 Months - Change from BL	-62.65 dB Standard Deviation 208.64	-37.33 dB Standard Deviation 173.46	-202.31 dB Standard Deviation 137.13	-98.73 dB Standard Deviation 127.09
Change in Mean Humphrey Visual Fields Sensitivity 24 Months - Change from BL	-104.15 dB Standard Deviation 194.50	-72.15 dB Standard Deviation 162.72	-227.89 dB Standard Deviation 149.73	-136.96 dB Standard Deviation 126.73
Change in Mean Humphrey Visual Fields Sensitivity 30 Months (retained implant) - Change from BL	-46.977 dB Standard Deviation 345.78	-58.64 dB Standard Deviation 275.09	-321.72 dB Standard Deviation 196.81	-211.82 dB Standard Deviation 145.25
Change in Mean Humphrey Visual Fields Sensitivity 30 Months (6 Months Post-Explant) - Change from BL	-82.67 dB Standard Deviation 185.60	-58.50 dB Standard Deviation 148.57	-188.64 dB Standard Deviation 122.33	-144.60 dB Standard Deviation 134.31

SECONDARY outcome

Timeframe: Baseline compared to 6, 12, 18, 24 and 30 months

Population: MITT Population

Change in Humphrey Visual Field Sensitivity over time

Outcome measures

Outcome measures
Measure	Low Dose - Implant n=20 Participants NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	Low Dose - Sham n=20 Participants Sham Implant in Fellow Eye (Low Dose Arm)	High Dose - Implant n=48 Participants NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina	High Dose - Sham n=48 Participants Sham Implant in Fellow Eye (High Dose Arm)
Mean Humphrey Visual Fields Sensitivity 30 Months with retained implant	1176.22 dB Standard Deviation 384.29	1173.32 dB Standard Deviation 340.09	695.97 dB Standard Deviation 251.57	787.30 dB Standard Deviation 322.72
Mean Humphrey Visual Fields Sensitivity 30 Months (6 Months Post-Explant)	1090.92 dB Standard Deviation 382.10	1056.08 dB Standard Deviation 406.65	752.78 dB Standard Deviation 345.78	782.60 dB Standard Deviation 382.68
Mean Humphrey Visual Fields Sensitivity Baseline	1142.43 dB Standard Deviation 446.33	1135.94 dB Standard Deviation 423.50	969.83 dB Standard Deviation 391.74	961.70 dB Standard Deviation 435.68
Mean Humphrey Visual Fields Sensitivity 6 Months	1141.21 dB Standard Deviation 438.07	1161.74 dB Standard Deviation 399.67	834.60 dB Standard Deviation 354.98	918.72 dB Standard Deviation 422.60
Mean Humphrey Visual Fields Sensitivity 12 Months	1143.78 dB Standard Deviation 409.76	1152.69 dB Standard Deviation 388.30	805.03 dB Standard Deviation 357.86	895.05 dB Standard Deviation 427.12
Mean Humphrey Visual Fields Sensitivity 18 Months	1079.78 dB Standard Deviation 440.81	1098.61 dB Standard Deviation 427.23	757.80 dB Standard Deviation 363.86	850.92 dB Standard Deviation 404.91
Mean Humphrey Visual Fields Sensitivity 24 Months	1038.28 dB Standard Deviation 430.12	1063.79 dB Standard Deviation 398.68	745.62 dB Standard Deviation 344.58	825.06 dB Standard Deviation 396.47

Adverse Events

Low Dose

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

High Dose

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose n=20 participants at risk NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye	High Dose n=48 participants at risk NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye
Nervous system disorders Cubital tunnel syndrome	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	0.00% 0/48 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Gastrointestinal disorders Acute appendicitis	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	2.1% 1/48 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	2.1% 1/48 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Musculoskeletal and connective tissue disorders Hypertrophic medial synovial plica with synovitis	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	2.1% 1/48 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Cardiac disorders Non-ischemic cardiomyopathy	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	2.1% 1/48 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).

Other adverse events

Additional Information

Patricia Davis, Sr. Director of Clinical Operations

Neurotech USA, Inc.

Phone: 401.333.3880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Low Dose n=20 participants at risk NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye	High Dose n=48 participants at risk NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye
Eye disorders Anterior Chamber Cell	35.0% 7/20 • Number of events 7 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	18.8% 9/48 • Number of events 9 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Anterior Chamber Flare	25.0% 5/20 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	18.8% 9/48 • Number of events 9 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Asthenopia	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	2.1% 1/48 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Cataract Subcapsular	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Conjunctival Haemorrhage	85.0% 17/20 • Number of events 17 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	79.2% 38/48 • Number of events 38 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Conjunctival Hyperaemia	60.0% 12/20 • Number of events 12 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	35.4% 17/48 • Number of events 17 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Conjunctival Oedema	15.0% 3/20 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Dellen	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Diplopia	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eye Discharge	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eye Inflammation	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eye Irritation	25.0% 5/20 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eye Pain	30.0% 6/20 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	25.0% 12/48 • Number of events 12 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eye Pruritis	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Eyelid Oedema	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Foreign Body Sensation in Eyes	15.0% 3/20 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	22.9% 11/48 • Number of events 11 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Hypotony of Eye	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Macular Oedema	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	10.4% 5/48 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Maculopathy	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Miosis	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	31.2% 15/48 • Number of events 15 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Ocular Hyperaemia	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Photophobia	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Photopsia	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Pupils Unequal	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	16.7% 8/48 • Number of events 8 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vision Blurred	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Visual Acuity Reduced	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	14.6% 7/48 • Number of events 7 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Visual Disturbance	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vitreous Detachment	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vitreous Disorder	25.0% 5/20 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	14.6% 7/48 • Number of events 7 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vitreous Floaters	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vitreous Haemorrhage	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Eye disorders Vitreous Opacities	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	10.4% 5/48 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
General disorders Implant Site Reaction	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Infections and infestations Influenza	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Infections and infestations Nasopharyngitis	20.0% 4/20 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	18.8% 9/48 • Number of events 9 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Infections and infestations Upper Respiratory Tract Infection	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Corneal Abrasion	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Periorbital Haematoma	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Post Procedural Complication	10.0% 2/20 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	8.3% 4/48 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Post Procedural Discomfort	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Procedural Pain	20.0% 4/20 • Number of events 4 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Injury, poisoning and procedural complications Suture Related Complication	25.0% 5/20 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	29.2% 14/48 • Number of events 14 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Investigations Intraocular Pressure Decreased	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	12.5% 6/48 • Number of events 6 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Investigations Intraocular Pressure Increased	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Musculoskeletal and connective tissue disorders Back Pain	5.0% 1/20 • Number of events 1 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	4.2% 2/48 • Number of events 2 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Nervous system disorders Headache	25.0% 5/20 • Number of events 5 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).
Psychiatric disorders Depression	0.00% 0/20 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).	6.2% 3/48 • Number of events 3 • Time of consent through Month 30 (study exit) Adverse events were followed from time of initial consent through 30 Months (study exit).