Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases
2 other identifiers
observational
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 18, 2013
CompletedJune 18, 2013
June 1, 2013
4 months
June 11, 2013
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
Eligibility Criteria
mild to moderate keratoconus cases
You may qualify if:
- keratoconus with a central corneal thickness (CCT) over 400µm,
- poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
- contact lens intolerance
You may not qualify if:
- apical scarring,
- ocular or systemic problem other than keratoconus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nisa Hastanesilead
Study Sites (1)
Ophthalmology Department, Nisa Hospital
Istanbul, 34196, Turkey (Türkiye)
Related 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.
PMID: 16761238RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ibrahim kocak, m.d
ophthalmologist
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 18, 2013
Study Start
July 1, 2012
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
June 18, 2013
Record last verified: 2013-06