Status:
COMPLETED
Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
Lead Sponsor:
Democritus University of Thrace
Conditions:
Keratoconus
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linki...
Eligibility Criteria
Inclusion
- be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
- present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.
- Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:
- an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
- an increase of 1.00 D or more in manifest cylinder
- an increase of 0.50 D or more in manifest refraction spherical equivalent.
Exclusion
- glaucoma
- suspicion for glaucoma
- IOP-lowering medications
- central corneal thickness (CCT) less than 400μm
- K-readings more than 60D
- history of herpetic keratitis
- corneal scarring
- severe eye dryness
- pregnancy or nursing
- current corneal infection
- or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450μm.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01845714
Start Date
April 1 2009
End Date
October 1 2012
Last Update
January 18 2017
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