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Manual Vs Microkeratome dissected corneal donor tissue in Descemets Stripping Endothelial Keratoplasty- Randomized Control Trial

Microkeratome dissected vs Manually dissected donor tissue for Descemet Stripping Endothelial Keratoplasty: A Randomised prospective comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022170
Enrollment
56
Registered
2019-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: Descemet stripping automated endothelial keratoplasty (DSAEK): Intervention of using Microkeratome dissected donor corneal lenticule will be done after the patient has been randomised t

Sponsors

Hyderabad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring corneal transplant diagnosed with irreversible endothelial dysfunction like 1.Fuchsâ?? dystrophy 2.Pseudophakic Bullous Keratopathy 3.Aphakic Bullous Keratopathy 4.Patients with graft failure after a previous Endothelial or Penetrating keratoplasty.

Exclusion criteria

Exclusion criteria: Patients with visual impairing co-morbidity like 1. Post Glaucoma filtering surgery 2. Pre-existing retinal disease like Age related macular degeneration 3. Amblyopia

Design outcomes

Primary

MeasureTime frame
Primary outcome 1-Incidence of donor detachment 2-Visual acuity Timepoint: Post operatively Day 1, Week 1 , Month 1 , 3 months and 6 months

Secondary

MeasureTime frame
1-Graft asymmetry 2-Endothelial cell density Timepoint: Post operatively Day 1, Week 1 , Month 1 , 3 months and 6 months

Countries

India

Contacts

Public ContactDr Ritu Mali

L V Prasad Eye Institute , MTC Campus , Patia , Bhubaneswar

sujata.abani@gmail.com06742653216

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026