Trial Outcomes & Findings for Clinical Outcomes With Bilateral Implantation of Odyssey IOLs (NCT NCT06550375)
NCT ID: NCT06550375
Last Updated: 2026-04-08
Results Overview
Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
3 months postoperative
Results posted on
2026-04-08
Participant Flow
Participant milestones
| Measure |
TECNIS Odyssey IOL
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TECNIS Odyssey IOL
n=40 Participants
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 6.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 months postoperativePhotopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Outcome measures
| Measure |
TECNIS Odyssey IOL
n=80 Eyes
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Visual Acuity at Distance (6m) logMAR
Binocular mesopic UDVA
|
-0.04 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Distance (6m) logMAR
Binocular mesopic CDVA
|
-0.05 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Distance (6m) logMAR
Monocular photopic UDVA
|
0.00 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Distance (6m) logMAR
Monocular photopic CDVA
|
-0.02 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Distance (6m) logMAR
Monocular mesopic UDVA
|
0.02 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Distance (6m) logMAR
Monocular mesopic CDVA
|
0.00 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Distance (6m) logMAR
Binocular photopic UDVA
|
-0.07 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Distance (6m) logMAR
Binocular photopic CDVA
|
-0.07 logMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 3 months postoperativePhotopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Outcome measures
| Measure |
TECNIS Odyssey IOL
n=80 eyes
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Visual Acuity at Intermediate (66cm) logMAR
Monocular photopic UIVA
|
0.06 logMAR
Standard Deviation 0.11
|
|
Visual Acuity at Intermediate (66cm) logMAR
Monocular photopic DCIVA
|
0.09 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Intermediate (66cm) logMAR
Monocular mesopic UIVA
|
0.12 logMAR
Standard Deviation 0.10
|
|
Visual Acuity at Intermediate (66cm) logMAR
Monocular mesopic DCIVA
|
0.11 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Intermediate (66cm) logMAR
Binocular photopic UIVA
|
0.03 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Intermediate (66cm) logMAR
Binocular photopic DCIVA
|
0.01 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Intermediate (66cm) logMAR
Binocular mesopic UIVA
|
0.04 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Intermediate (66cm) logMAR
Binocular mesopic DCIVA
|
0.04 logMAR
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 3 months postoperativePhotopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Outcome measures
| Measure |
TECNIS Odyssey IOL
n=80 eyes
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Visual Acuity at Near (40cm) logMAR
Monocular photopic UNVA
|
0.10 logMAR
Standard Deviation 0.11
|
|
Visual Acuity at Near (40cm) logMAR
Monocular photopic DCNVA
|
0.07 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Near (40cm) logMAR
Monocular mesopic UNVA
|
0.11 logMAR
Standard Deviation 0.10
|
|
Visual Acuity at Near (40cm) logMAR
Monocular mesopic DCNVA
|
0.09 logMAR
Standard Deviation 0.09
|
|
Visual Acuity at Near (40cm) logMAR
Binocular photopic UNVA
|
0.02 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Near (40cm) logMAR
Binocular photopic DCNVA
|
0.02 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Near (40cm) logMAR
Binocular mesopic UNVA
|
0.03 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Near (40cm) logMAR
Binocular mesopic DCNVA
|
0.03 logMAR
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 3 months postoperativePhotopic and mesopic, binocular and monocular, and uncorrected and distance corrected
Outcome measures
| Measure |
TECNIS Odyssey IOL
n=80 eyes
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Visual Acuity at Near (33cm) logMAR
Monocular photopic UNVA
|
0.04 logMAR
Standard Deviation 0.10
|
|
Visual Acuity at Near (33cm) logMAR
Monocular photopic DCNVA
|
0.01 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Near (33cm) logMAR
Monocular mesopic UNVA
|
0.06 logMAR
Standard Deviation 0.11
|
|
Visual Acuity at Near (33cm) logMAR
Monocular mesopic DCNVA
|
0.04 logMAR
Standard Deviation 0.10
|
|
Visual Acuity at Near (33cm) logMAR
Binocular photopic UNVA
|
-0.02 logMAR
Standard Deviation 0.07
|
|
Visual Acuity at Near (33cm) logMAR
Binocular photopic DCNVA
|
-0.02 logMAR
Standard Deviation 0.06
|
|
Visual Acuity at Near (33cm) logMAR
Binocular mesopic UNVA
|
0.00 logMAR
Standard Deviation 0.08
|
|
Visual Acuity at Near (33cm) logMAR
Binocular mesopic DCNVA
|
-0.01 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months postoperativeThe AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome.
Outcome measures
| Measure |
TECNIS Odyssey IOL
n=40 Participants
TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL
|
|---|---|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Overall vision rated as "Excellent" or "Very Good"
|
34 Participants
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Distance vision rated as "Excellent" or "Very Good"
|
40 Participants
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Intermediate vision rated as "Excellent" or "Very Good"
|
35 Participants
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
Near vision rated as "Excellent" or "Very Good"
|
31 Participants
|
Adverse Events
TECNIS Odyssey IOL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place