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NCT04562064 Clinical Trial

Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Keratoconus Clinical Trial

Official title:
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04562064
Other study ID # PICR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date November 2022

Study information
Verified date August 2022
Source Assiut University
Contact Magdi M Mostafa, MD
Phone 01093122344
Email magdimohammad2013@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date November 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• corneal tomography scans
corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system

Locations
Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly The changes of anterior corneal surface including ?at (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly 1 month
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