Trial Outcomes & Findings for Optimizing the Ocular Surface Prior to Cataract Surgery (NCT NCT02766907)
NCT ID: NCT02766907
Last Updated: 2019-03-19
Results Overview
Assessed by corneal topography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change from Baseline to 1 month
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
Control
Retrospective review of debridement without cryopreserved amniotic membrane
|
Study
prospective arm receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for epithelial basement membrane dystrophy (EBMD)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing the Ocular Surface Prior to Cataract Surgery
Baseline characteristics by cohort
| Measure |
Study
n=9 Participants
prospective arm receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
|
Control
n=9 Participants
Retrospective review of debridement without cryopreserved amniotic membrane
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 7.5 • n=39 Participants
|
66.5 years
STANDARD_DEVIATION 5.9 • n=41 Participants
|
70 years
STANDARD_DEVIATION 7.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=39 Participants
|
9 participants
n=41 Participants
|
18 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 1 monthAssessed by corneal topography
Outcome measures
| Measure |
Study
n=9 Participants
prospective arm receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
|
Control
n=9 Participants
Retrospective review of debridement without cryopreserved amniotic membrane
|
|---|---|---|
|
Change in Intraocular Lens Calculation
|
1.56 D
Standard Deviation 1.6
|
0.94 D
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Change from Baseline to 1 monthAssessed using biometry and calculated using Holladay I formula
Outcome measures
| Measure |
Study
n=9 Participants
prospective arm receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
|
Control
n=9 Participants
Retrospective review of debridement without cryopreserved amniotic membrane
|
|---|---|---|
|
Change in Intraocular Lens Power Calculation
|
1.18 D
Standard Deviation 1.2
|
0.79 D
Standard Deviation 0.5
|
Adverse Events
Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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