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Pocket Versus Tunnel ICRS for Treatment of Keratoconus

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intrastromal corneal ring segment implantation (Pocket)
Intrastromal corneal ring segment implantation (Tunnel)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Femtosecond laser-assisted ICRS, Central keratoconus, KeraRing

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with progressive keratoconus with maximum keratometry (Kmax) between 50-65 diopters Central keratoconus (Keratoconus with steepest corneal point within the central 3 mm zone). Clear corneal with a minimum pachymetry of 400 μm. Exclusion Criteria: Corneal scars Patients with advanced keratoconus with Kmax > 65 diopters. Non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone). Previous corneal cross-linking and/or ocular surgery. Systemic diseases such as diabetes mellitus and autoimmune diseases

Sites / Locations

  • Tiba Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pocket ICRS

Tunnel ICRS

Arm Description

Patients in this group are planned to undergo KeraRing implantation through a femtosecond laser-assisted corneal pocket creation for the management of their central keratoconus.

Patients in this group are planned to undergo KeraRing implantation through a femtosecond laser-assisted corneal tunnel creation for the management of their central keratoconus.

Outcomes

Primary Outcome Measures

Uncorrected distance visual acuity (UDVA)
Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Corrected distance visual acuity (CDVA)
Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Postoperative Refraction
Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer
Postoperative keratometry
Postoperative keratometry as measured by Scheimpflug imaging Pentacam

Secondary Outcome Measures

Full Information

First Posted
February 19, 2023
Last Updated
May 23, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05748847
Brief Title
Pocket Versus Tunnel ICRS for Treatment of Keratoconus
Official Title
Pocket Versus Tunnel Intrastromal Corneal Ring Segment Implantation (KeraRing) for the Management of Central Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Keratoconus is a corneal degenerative disease characterized by corneal thinning and subsequent development of irregular astigmatism, diminution of vision and loss of best-corrected visual acuity. Management of keratoconus includes halting disease progression through a corneal strengthening procedure called corneal collagen cross-linking (CXL) which usually results in stabilizing the condition but with no improvement in visual acuity or quality. Intrastromal corneal ring segment (ICRS) implantation is a well-established procedure for the management of moderate keratoconus with a corneal flattening effect that is associated with improvement of visual acuity and reduction of optical aberrations. The aim of the study is to evaluate and compare the visual, refractive and topographic outcomes of two different femtosecond laser assisted surgical techniques to create a corneal stromal pocket or a tunnel for implantation of ICRS for the management of central keratoconus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Femtosecond laser-assisted ICRS, Central keratoconus, KeraRing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pocket ICRS
Arm Type
Active Comparator
Arm Description
Patients in this group are planned to undergo KeraRing implantation through a femtosecond laser-assisted corneal pocket creation for the management of their central keratoconus.
Arm Title
Tunnel ICRS
Arm Type
Active Comparator
Arm Description
Patients in this group are planned to undergo KeraRing implantation through a femtosecond laser-assisted corneal tunnel creation for the management of their central keratoconus.
Intervention Type
Procedure
Intervention Name(s)
Intrastromal corneal ring segment implantation (Pocket)
Intervention Description
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 4-mm width.
Intervention Type
Procedure
Intervention Name(s)
Intrastromal corneal ring segment implantation (Tunnel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uncorrected distance visual acuity (UDVA)
Description
Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Time Frame
6 months
Title
Corrected distance visual acuity (CDVA)
Description
Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Time Frame
6 months
Title
Postoperative Refraction
Description
Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer
Time Frame
6 months
Title
Postoperative keratometry
Description
Postoperative keratometry as measured by Scheimpflug imaging Pentacam
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with progressive keratoconus with maximum keratometry (Kmax) between 50-65 diopters Central keratoconus (Keratoconus with steepest corneal point within the central 3 mm zone). Clear corneal with a minimum pachymetry of 400 μm. Exclusion Criteria: Corneal scars Patients with advanced keratoconus with Kmax > 65 diopters. Non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone). Previous corneal cross-linking and/or ocular surgery. Systemic diseases such as diabetes mellitus and autoimmune diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abdel-Radi, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiba Eye Center
City
Assiut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33579160
Citation
Izquierdo L Jr, Rodriguez AM, Sarquis RA, Altamirano D, Henriquez MA. Intracorneal circular ring implant with femtosecond laser: Pocket versus tunnel. Eur J Ophthalmol. 2022 Jan;32(1):176-182. doi: 10.1177/1120672121994729. Epub 2021 Feb 12.
Results Reference
result

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Pocket Versus Tunnel ICRS for Treatment of Keratoconus

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