MedTrace Logo

Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK

NCT06652321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-22

No results posted yet for this study

Summary

To evaluate the clinical outcomes (pos toperative best corrected visual acuity, endothelial count) and anatomical results (interface smoothness) of DSAEK with Femto LDV-prepared grafts from the endothelial side.

Conditions

  • Pseudophakic Bullous Keratopathy
  • Fuchs' Endothelial Dystrophy

Interventions

PROCEDURE

Endothelial Side Up Femtosecond Laser Assisted DSAEK

The Femto LDV Z8 laser system will be set to create a 100 μm thick graft with a 7.5 mm diameter. The graft will be inverted, placed endothelial side up in the anterior chamber, and coated with Viscoat. A fixation ring will center the graft by holding the scleral rim with forceps. After cutting, the cornea should remain endothelium-up, stained with Trypan Blue, and dissected using a blunt spatula. The graft will be placed on a Busin glide and coated with Viscoat. A 3-4 mm corneal incision will be made, and Descemet's membrane will be marked and stripped. The graft will be inserted using the Busin glide, spreading automatically. A small air bubble will fill the anterior chamber to compress the graft for 10 minutes.

Sponsors & Collaborators

  • Dar El Oyoun Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652321 on ClinicalTrials.gov