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Pocket Versus Tunnel ICRS for Treatment of Keratoconus

NCT05748847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-10-31

No results posted yet for this study

Summary

Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.

Conditions

  • Keratoconus

Interventions

PROCEDURE

Intrastromal corneal ring segment implantation (Pocket)

Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted pocket creation. The device creates an intrastromal corneal pocket of 8-mm diameter and a depth of nearly 80% of the corneal thickness at the thinnest location with a superior tunnel incision at 90° of 5-mm width.

PROCEDURE

Intrastromal corneal ring segment implantation (Tunnel)

Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted tunnel creation. The device creates an intrastromal tunnel with a depth of nearly 80% of the corneal thickness at the site of implantation. The tunnel inner and outer diameters are at 5 and 6 mm from the corneal center, respectively with the incision located at the steepest keratometry axis.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mahmoud Abdel-Radi, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-04-15
Completion
2023-04-15

Countries

  • Egypt

Study Locations

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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 NCT05748847 on ClinicalTrials.gov