Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04562064
Collaborator
(none)
44
1
23
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: corneal tomography scans

Study Design

Study Type:
Observational
Anticipated Enrollment :
44 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
keratoconus group

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut Faculty of Medicine Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04562064
Other Study ID Numbers:
  • PICR
First Posted:
Sep 24, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022