Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases

June 17, 2013 updated by: Ibrahim Kocak, Nisa Hastanesi
Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34196
        • Ophthalmology Department, Nisa Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

mild to moderate keratoconus cases

Description

Inclusion Criteria:

  • keratoconus with a central corneal thickness (CCT) over 400µm,
  • poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
  • contact lens intolerance

Exclusion Criteria:

  • apical scarring,
  • ocular or systemic problem other than keratoconus

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mild to moderate keratoconus cases
keratoconus with a central corneal thickness (CCT) over 400µm, poor corrected visual acuity (≤0.4 at Snellen visual acuity charts), contact lens intolerance, no apical scarring, no ocular or systemic problem other than keratoconus
Procedure: radial keratotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings
Time Frame: after surgery - 12 to 52 months
Preoperative and postoperative uncorrected visual acuity, best spectacle corrected visual acuity, and keratometer readings will be reviewed retrospectively. As reviewed follow up time range is 12 to 52 months, time frame is assessed as " 12 to 52 months"
after surgery - 12 to 52 months

Collaborators and Investigators

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

Sponsor

Nisa Hastanesi

Investigators

  • Principal Investigator: ibrahim kocak, m.d, Ophthalmologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.IMU.0.05.05-11
  • B32IMU0050511 (Other Identifier: Istanbul Medipol University clinical trials etics committee)

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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