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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01845714

Enrollment

Registered

2013-05-03

Start date

2009-04-30

Completion date

2012-10-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, Corneal cross Linking, Topo guided PRK, Quality of Life

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.

Interventions

PROCEDURECorneal Cross Linking

PROCEDURECorneal Cross Linking combined with topoguided PRK

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Vision Specific quality of Life (VS-QoL)	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026