Health TrialsbyHealthPanel

Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK

ConditionsPseudophakic Bullous KeratopathyFuchs' Endothelial Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDar El Oyoun Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Endothelial Side Up Femtosecond Laser Assisted DSAEK

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Inverted DSAEKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Best spectacle-corrected visual acuity

Measurement Tool: Snellen chart Unit of Measure: LogMAR

Time frame
after 3 and 6 months
2

Endothelial cell count using specular microscopy

Measurement Tool: Specular microscopy Time Frame: After 3 months and 6 months

Time frame
after 3 and 6 months

Secondary outcomes

1

Total central corneal thickness (CCT)

Measurement Tool: Anterior Segment Optical Coherence Tomography (AS-OCT) Unit of Measure: Micrometers (µm)

Time frame
after 3 and 6 months
2

Donor Corneal Endothelial Thickness (CET)

Measurement Tool: Anterior Segment Optical Coherence Tomography (AS-OCT) Unit of Measure: Micrometers (µm)

Time frame
After 3 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dar El Oyoun Hospital

Lead sponsor

Source ClinicalTrials.gov
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