Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

• Conditions: Keratoconus
• Interventions: Device: corneal tomography scans

• Registration Number: NCT04562064
• Lead Sponsor: Assiut University

Brief Summary

keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.

Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Study Start: 2020-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25
• Primary Completion: 2022-09
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
• Contact lens intolerance.
• Thinnest location is more than 400 um.
• Maximum keratometry (Kmax) between 48 and 64 D.
• Clear cornea with no Vogt's striae.

Exclusion Criteria

• Previous corneal surgery.
• Grade IV with corneal scarring.
• Concurrent corneal disease in addition to KC.
• Autoimmune or systemic connective tissue diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
keratoconus group	corneal tomography scans	patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included

Primary Outcome Measures

Name	Time	Method
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly	1 month	The changes of anterior corneal surface including flat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt