Pocket Versus Tunnel ICRS for Treatment of Keratoconus

Keratoconus Clinical Trial

Official title:

Pocket Versus Tunnel Intrastromal Corneal Ring Segment Implantation (KeraRing) for the Management of Central Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748847
• Other study ID #: PVTICRS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Patients with progressive keratoconus with maximum keratometry (Kmax) between 50-65 diopters

2. Central keratoconus (Keratoconus with steepest corneal point within the central 3 mm zone).

3. Clear corneal with a minimum pachymetry of 400 µm.

Exclusion Criteria:

1. Corneal scars

2. Patients with advanced keratoconus with Kmax > 65 diopters.

3. Non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone).

4. Previous corneal cross-linking and/or ocular surgery.

5. Systemic diseases such as diabetes mellitus and autoimmune diseases

Related Conditions & MeSH terms

• Keratoconus

Intervention

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 4-mm width.
• 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.

Locations

Country	Name	City	State
Egypt	Tiba Eye Center	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected distance visual acuity (UDVA)	Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation	6 months
Primary	Corrected distance visual acuity (CDVA)	Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation	6 months
Primary	Postoperative Refraction	Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer	6 months
Primary	Postoperative keratometry	Postoperative keratometry as measured by Scheimpflug imaging Pentacam	6 months