Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.

Democritus University of Thrace0 sites28 target enrollmentApril 2009

ConditionsKeratoconus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Keratoconus
Sponsor: Democritus University of Thrace
Enrollment: 28
Primary Endpoint: Vision Specific quality of Life (VS-QoL)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Democritus University of Thrace

Responsible Party

Principal Investigator

Georgios Labiris

Assistant Professor

Democritus University of Thrace

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.