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CompletedNCT01845714Updated Jan 18, 2017

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

An interventional study of Corneal Cross Linking and Corneal Cross Linking combined with topoguided PRK in Keratoconus, sponsored by Democritus University of Thrace. Completed. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Democritus University of Thrace · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
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Study 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.

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Conditions studied

  • Keratoconus

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Keywords

  • Keratoconus
  • Corneal cross Linking
  • Topo guided PRK
  • Quality of Life
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In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 28 is below the median of 40 across 203 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Cross Linking Group (CxL group)

    Patients that received CXL

    Procedure: Corneal Cross Linking

  • Active comparator
    Cross Linking with topo-guided PRK (tCxL)

    Patients that received tCxL

    Procedure: Corneal Cross Linking combined with topoguided PRK

Interventions

  • ProcedureCorneal Cross Linking
  • ProcedureCorneal Cross Linking combined with topoguided PRK
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What researchers measure

Primary outcomes

  1. Vision Specific quality of Life (VS-QoL)

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 23807006 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01845714
Lead sponsor
Democritus University of Thrace
Responsible party
Georgios Labiris (Assistant Professor, Democritus University of Thrace) — Principal investigator
First posted
May 3, 2013
Start date
Apr 2009
Primary completion
Apr 2011
Completion
Oct 2012
Last update
Jan 18, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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