Trial Outcomes & Findings for A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System (NCT NCT02890303)
NCT ID: NCT02890303
Last Updated: 2018-04-27
Results Overview
A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
During surgery
Results posted on
2018-04-27
Participant Flow
This study enrolled patients at 8 clinical study sites, with symptomatic age-related lens cataract desiring lens extraction and IOL implantation. The last patient was enrolled in the study in December 2016.
Participant milestones
| Measure |
Zepto Capsulotomy
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less)
Zepto System: Anterior Capsulotomy using the Zepto System.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Baseline characteristics by cohort
| Measure |
Zepto Capsulotomy
n=100 Participants
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less)
Zepto System: Anterior Capsulotomy using the Zepto System.
|
|---|---|
|
Age, Customized
|
69.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=5 Participants
|
|
Intraocular Pressure
|
16 mm Hg
n=5 Participants
|
|
Manifest Refraction
|
96 Participants
n=5 Participants
|
|
Uncorrected distance visual acuity (UCVA)
|
138 ft
n=5 Participants
|
|
Best spectacle corrected distance visual acuity (BSCVA)
|
40 ft
n=5 Participants
|
|
Slit Lamp
% of Normal treatment lids
|
97 percentage of participants
n=5 Participants
|
|
Slit Lamp
% presenting with 1 + Meibomian gland dysfunction
|
7 percentage of participants
n=5 Participants
|
|
Slit Lamp
% of Normal cornea
|
97 percentage of participants
n=5 Participants
|
|
Slit Lamp
% 1 + punctuate epithelial keratitis/ keratopathy
|
1 percentage of participants
n=5 Participants
|
|
Slit Lamp
% with Waite Beecham Lines - mild
|
1 percentage of participants
n=5 Participants
|
|
Slit Lamp
% with faint stromal scarring
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with normal findings
|
87 percentage of participants
n=5 Participants
|
|
Fundus Examination
% presented with posterior vitreous detachment
|
7 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with mild macular drusen
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with peripheral drusen
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with mild epiretinal membrane
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with choroidal nevus
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with post vitreous degeneration
|
1 percentage of participants
n=5 Participants
|
|
Fundus Examination
% with a tilted disc
|
1 percentage of participants
n=5 Participants
|
|
Dilated Pupil Size
|
8 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: During surgeryA successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases).
Outcome measures
| Measure |
Zepto Capsulotomy
n=100 Participants
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less)
Zepto System: Anterior Capsulotomy using the Zepto System.
|
|---|---|
|
Complete Capsulotomy
|
98 participants
|
Adverse Events
Zepto Capsulotomy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zepto Capsulotomy
n=100 participants at risk
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less)
Zepto System: Anterior Capsulotomy using the Zepto System.
|
|---|---|
|
Eye disorders
Epithelial Erosion
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
Eye disorders
Macular Edema
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
Eye disorders
Anterior Capsule Tear
|
2.0%
2/100 • Number of events 2 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
Eye disorders
Posterior Tear without Vitreous Loss
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
General disorders
Headache
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
Eye disorders
Elevated IOP
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
|
Eye disorders
Ache in Treatment Eye
|
1.0%
1/100 • Number of events 1 • Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place