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Clinical Trials/NCT04562064
NCT04562064
Unknown
Not Applicable

Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Assiut University1 site in 1 country44 target enrollmentDecember 1, 2020
ConditionsKeratoconus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratoconus
Sponsor
Assiut University
Enrollment
44
Locations
1
Primary Endpoint
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
November 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Abbas

Principal investigator

Assiut University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly

Time Frame: 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

Study Sites (1)

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