Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus

Not Applicable

• Conditions: Keratoconus
• Interventions: Other: corneal ring segments

• Registration Number: NCT05055349
• Lead Sponsor: Minia University

Brief Summary

To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus

Detailed Description

* The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.

* Fourty eyes will be evenly allocated into two groups:

Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.

Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).

• An informed written consent to be involved in the study will be obtained from each patient.

Study Timeline

• Study Start: 2019-11-28
• Study First Submitted: 2021-03-25
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Keratoconus grade I to III according to the Amsler-Krumeich classification

Exclusion Criteria

• Acute hydrops or grade IV keratoconus
• Any ocular diseases or surgeries
• Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
• Corneal pacities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toric phakic posterior IOL implantation and corneal collagen cross linking	corneal ring segments	20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).
corneal collagen cross linking and intrastromal corneal keraring segments.	corneal ring segments	20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments

Primary Outcome Measures

Name	Time	Method
pentacam readings	1 month	a device that read topometric corneal data and other data

Trial Locations

Locations (1)

Ahmed Maher Khalafallah; 🇪🇬 Minya, Egypt