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NCT01879631 Clinical Trial

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

Radial Keratotomy in Keratoconus Cases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01879631
Other study ID # B.30.2.IMU.0.05.05-11
Secondary ID B32IMU0050511
Status Completed
Phase N/A
First received June 11, 2013
Last updated June 17, 2013
Start date July 2012
Est. completion date December 2012

Study information
Verified date June 2013
Source Nisa Hastanesi
Contact n/a
Is FDA regulated No
Health authority Ministry of health, Turkish Republic: Turkey
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• radial keratotomy

Locations
Country Name City State
Turkey Ophthalmology Department, Nisa Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Nisa Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Utine CA, Bayraktar S, Kaya V, Kucuksumer Y, Eren H, Perente I, Yilmaz OF. Radial keratotomy for the optical rehabilitation of mild to moderate keratoconus: more than 5 years' experience. Eur J Ophthalmol. 2006 May-Jun;16(3):376-84. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings 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 No