Corneal transplant clinical trial

Microthin Descemets Stripping Automated Endothelial Keratoplasty (Microthin-DSAEK) vs Descemets Membrane Endothelial Keratoplasty (DMEK) - RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10578843

Enrollment

Registered

2020-01-08

Start date

2016-10-01

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal endothelial failure Eye Diseases

Interventions

1. All patients eligible for the trial will be randomised either to the DMEK arm or MT-DSAEK (Micro thin DSAEK) arm. 2. Randomisation: One eye per patient will be randomised to either

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Visual compromise due to corneal endothelial decompensation 2. Aged 18 years or above

Exclusion criteria

Exclusion criteria: Patients with several ocular comorbidities in addition to corneal endothelial decompensation will be excluded

Design outcomes

Primary

Measure	Time frame
Best corrected visual acuity measured using LogMar values at 12 months	—

Secondary

Measure	Time frame
1. Visual Acuity: An optician trained in the use of ETDRS charts will check the autorefractive reading and then will measure BCVA at 3, 6 and 9 months 2. Refractive cylinder: Results will be taken with an autorefractometer 3 times or until till a consistent reading will be obtained. The last 3 results will be averaged. Refraction will be then checked manually by a trained optician when BCVA will be measured 3. Central corneal thickness: Central corneal thickness will be measured by anterior OCT. This will be performed by an experienced trained technician with all scans independently verified by a doctor not involved with the care of the patients 4. Endothelial cell density: The cell density (cells/mm²) will be measured using specular microscopy at 6 and 12 months 5. Patient functional questionnaire: Patients will be asked to fill out a standard visual function questionnaire at each time point (VF 14) – there are 14 questions related to visual function and collected at 6 and 12 months 6. Complications: Rate of intraoperative and post-operative complications will be analysed between the two groups	—

Measure

Time frame

1. Visual Acuity: An optician trained in the use of ETDRS charts will check the autorefractive reading and then will measure BCVA at 3, 6 and 9 months 2. Refractive cylinder: Results will be taken with an autorefractometer 3 times or until till a consistent reading will be obtained. The last 3 results will be averaged. Refraction will be then checked manually by a trained optician when BCVA will be measured 3. Central corneal thickness: Central corneal thickness will be measured by anterior OCT. This will be performed by an experienced trained technician with all scans independently verified by a doctor not involved with the care of the patients 4. Endothelial cell density: The cell density (cells/mm²) will be measured using specular microscopy at 6 and 12 months 5. Patient functional questionnaire: Patients will be asked to fill out a standard visual function questionnaire at each time point (VF 14) – there are 14 questions related to visual function and collected at 6 and 12 months 6. Complications: Rate of intraoperative and post-operative complications will be analysed between the two groups

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026