Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

August 24, 2022 updated by: Ahmed Mohamed Abbas, Assiut University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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