Trial Outcomes & Findings for Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (NCT NCT00744796)

Last Updated: 2020-12-11

Results Overview

Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances.

Recruitment status

COMPLETED

Target enrollment

21 participants

Primary outcome timeframe

6-9 months Post-Operative

Results posted on

2020-12-11

Participant Flow

Twenty one patients from UT Southwestern Medical Center's Ophthalmology clinic were included.

Participant milestones

Participant milestones
Measure	DSAEK Group Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Pre-operative STARTED	21
Pre-operative COMPLETED	21
Pre-operative NOT COMPLETED	0
Post-Operative Day 1 STARTED	21
Post-Operative Day 1 COMPLETED	21
Post-Operative Day 1 NOT COMPLETED	0
Post-Operative 3-6 Months STARTED	21
Post-Operative 3-6 Months COMPLETED	21
Post-Operative 3-6 Months NOT COMPLETED	0
Post-Operative 6-9 Months STARTED	21
Post-Operative 6-9 Months COMPLETED	9
Post-Operative 6-9 Months NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	DSAEK Group Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Post-Operative 6-9 Months Lost to Follow-up	12

Baseline Characteristics

Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSAEK Group n=21 Participants Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Age, Customized <=18 years	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	4 Participants n=5 Participants
Age, Customized >=65 years	17 Participants n=5 Participants
Sex/Gender, Customized Female	9 Participants n=5 Participants
Sex/Gender, Customized Male	12 Participants n=5 Participants
Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/200	0 Participants n=5 Participants
Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/50 and >20/200	5 Participants n=5 Participants
Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/20 and >20/50	12 Participants n=5 Participants
Best-Spectacle Corrected Visual Acuity (BSCVA) Hand Motion only	1 Participants n=5 Participants
Best-Spectacle Corrected Visual Acuity (BSCVA) Finger Count only	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-9 months Post-Operative

Population: The number of participant, for analysis, were determined per protocol.

Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances.

Outcome measures

Outcome measures
Measure	DSAEK Group n=21 Participants Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Best Spectacle Corrected Visual Acuity (BSCVA) hand motion only	1 Participants
Best Spectacle Corrected Visual Acuity (BSCVA) finger count only	3 Participants
Best Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/200	7 Participants
Best Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/50 and >20/200	9 Participants
Best Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/20 and >20/50	1 Participants

PRIMARY outcome

Timeframe: 6 to 9 Months Post-Operative

The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used.

Outcome measures

Outcome measures
Measure	DSAEK Group n=21 Participants Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Central Corneal Thickness	686.6 micrometer Standard Deviation 72

PRIMARY outcome

Timeframe: 6 to 9 Months Post-Operative

Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea.

Outcome measures

Outcome measures
Measure	DSAEK Group n=21 Participants Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
Peripheral Corneal Thickness	710 micrometer Standard Deviation 105

Adverse Events

DSAEK Group

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

Dr. Vinod Mootha

University of Texas Southwestern Medical Center

Phone: 214-648-3837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place