Trial Outcomes & Findings for A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients (NCT NCT01373580)
NCT ID: NCT01373580
Last Updated: 2018-03-29
Results Overview
75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
373 participants
Primary outcome timeframe
24 Months
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
Raindrop
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Overall Study
STARTED
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373
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Overall Study
COMPLETED
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317
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Overall Study
NOT COMPLETED
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56
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients
Baseline characteristics by cohort
| Measure |
Raindrop
n=373 Participants
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Age, Continuous
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51.3 Years
STANDARD_DEVIATION 4.3 • n=99 Participants
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Sex: Female, Male
Female
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204 Participants
n=99 Participants
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Sex: Female, Male
Male
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169 Participants
n=99 Participants
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Race/Ethnicity, Customized
Caucasian
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290 Participants
n=99 Participants
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Race/Ethnicity, Customized
African American
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10 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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6 Participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic
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52 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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15 Participants
n=99 Participants
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Region of Enrollment
United States
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373 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 24 Months75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline
Outcome measures
| Measure |
Raindrop
n=344 Participants
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye
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336 Count of Participants
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SECONDARY outcome
Timeframe: at 6 months postoperative and all subsequent visitsPopulation: Numbers analyzed at each timepoint differ due to participant availability
Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.
Outcome measures
| Measure |
Raindrop
n=373 Participants
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@6M w/loss >/= 2 lines of BCVA
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0 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@18M w/BCDVA or BCNVA < 20/40
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0 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@24M w/BCDVA or BCNVA < 20/40
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0 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@9M w/loss >/= 2 lines of BCVA
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1 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@12M w/loss >/= 2 lines of BCVA
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1 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@18M w/loss>/= 2 lines of BCVA
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1 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participant@24M w/loss >/= 2 lines of BCVA
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1 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@6M w/BCDVA or BCNVA < 20/40
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0 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@9M w/BCDVA or BCNVA < 20/40
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1 Count of Participants
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Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
# of participants@12M w/BCDVA or BCNVA < 20/40
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0 Count of Participants
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SECONDARY outcome
Timeframe: At 6 months postoperative and all subsequent visitsPopulation: Numbers analyzed at each timepoint differ due to participant availability.
Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.
Outcome measures
| Measure |
Raindrop
n=373 Participants
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
#of participants@6M w/>2D increase in astigmatism
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0 Count of Participants
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Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
#of participants@9M w/>2D increase in astigmatism
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0 Count of Participants
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Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
#of participants@12M w/>2D increase in astigmatism
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0 Count of Participants
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Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
#of participants@18M w/>2D increase in astigmatism
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0 Count of Participants
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Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
#of participants@24M w/>2D increase in astigmatism
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0 Count of Participants
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Adverse Events
Raindrop
Serious events: 25 serious events
Other events: 115 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Raindrop
n=373 participants at risk
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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General disorders
Death
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Gastrointestinal disorders
Hospitalization due to Ischemic Colitis
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Respiratory, thoracic and mediastinal disorders
Hospitalization due to Pneumonia
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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General disorders
Hospitalization due to adverse reaction to medication
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0.54%
2/373 • Number of events 2 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Nervous system disorders
Hospitalization for Transient Ischemic Attack
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Blood and lymphatic system disorders
Hospitalization for elevated blood sugar
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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General disorders
Hospitalization for fainting/upper extremity pain - no formal diagnosis
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Cardiac disorders
Hospitalization secondary to heart disease
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2.7%
10/373 • Number of events 10 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Surgical and medical procedures
Hospitalization secondary to other surgery
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2.1%
8/373 • Number of events 8 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Musculoskeletal and connective tissue disorders
Infection secondary to achilles tendon surgery
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Melting of the flap
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Surgery to repair orbital bone fracture
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Other adverse events
| Measure |
Raindrop
n=373 participants at risk
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
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|---|---|
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Eye disorders
Ocular infection
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1.9%
7/373 • Number of events 8 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Epithelial ingrowth
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2.9%
11/373 • Number of events 13 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Loss in BCDVA of > 2 lines (11 letters or more) at 3 months or later
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3.8%
14/373 • Number of events 17 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Late onset of haze beyond 6 months with loss of 2 lines (10 letters) or more BCVA
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1.1%
4/373 • Number of events 4 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Cataract (with loss in BCDVA greater than or equal to 2 lines at any time
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0.54%
2/373 • Number of events 2 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Increase in Intraocular Pressure of greater than 10mmHg above baseline
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1.9%
7/373 • Number of events 10 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Diffuse Lamellar Keratitis (DLK)
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1.6%
6/373 • Number of events 6 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Secondary Surgical Intervention
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14.5%
54/373 • Number of events 62 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Posterior Vitreous Detachment
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Transient Visual Disturbance
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Anterior Uveitis
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1.1%
4/373 • Number of events 5 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Corneal Epithelial Defect Involving the Keratectomy
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0.54%
2/373 • Number of events 2 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Broken Orbital Bone
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Eye disorders
Lost, Misaligned, or Misplaced Flap
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0.27%
1/373 • Number of events 1 • Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36
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Additional Information
Tracy Shwaery, Global Clinical Research Manager
ReVision Optics
Phone: 9497072740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agreed to hold this information in confidence and not to disclose it to any third parties for a period of three years from the date of this agreement, or until this information becomes a matter of public knowledge or until a formal agreement for that purpose has been entered into by the parties.
- Publication restrictions are in place
Restriction type: OTHER