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 Thrace

Status

Completed

Conditions

Keratoconus

Treatments

Procedure: Corneal Cross Linking combined with topoguided PRK

Procedure: Corneal Cross Linking

Study type

Interventional

Funder types

Other

Identifiers

NCT01845714

EIT-KC-VSQOL3

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

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.