NCT05748847

Pocket Versus Tunnel ICRS for Treatment of Keratoconus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• Keratoconus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-04-15
• Completion: 2023-04-15
• First posted: 2023-03-01
• Last updated: 2024-10-31

Locations

1 site across 1 country: Egypt