Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 30, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedJanuary 18, 2017
January 1, 2017
2 years
April 30, 2013
January 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vision Specific quality of Life (VS-QoL)
3 years
Study Arms (2)
Cross Linking Group (CxL group)
ACTIVE COMPARATORPatients that received CXL
Cross Linking with topo-guided PRK (tCxL)
ACTIVE COMPARATORPatients that received tCxL
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: 10.1097/ICO.0b013e318296e13c. No abstract available.
PMID: 23807006RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 30, 2013
First Posted
May 3, 2013
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
October 1, 2012
Last Updated
January 18, 2017
Record last verified: 2017-01