Impact of corneal collagen cross-linking on vision-related quality of life in patients with progressive keratoconus

• Conditions: H18.6; Keratoconus

• Registration Number: DRKS00030330
• Lead Sponsor: Augenklinik des Universitätsklinikums Hamburg-Eppendorf (UKE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-09-03
• Study Start: 2022-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

keratoconus (See reference [1]):
-KISA-index >100 mit I-S >1.4 and/or Kmax>47
-progressive keratoconus:
(based on the „Global consensus on keratoconus and extatic diseases[2]): Changes in at least two of the following categories:
1. progressive steepening of the anterior corneal surface (topography)
2. progressive steepening of the posterior corneal surface (tomography)
3. progressive thinning of the corneal thickness
-> no specific cut-offs due to the recommendation of the „global consensus because different diagnostic devices were used for diagnosing keratoconus (Oculus Pentacam; Ziemer Galilei).
-> in case of missing corneal diagnostic data to determine a potential progression of the disease, the following alternative criteria are used [3]:
-decrease of the best corrected visual acuity >= 2 lines (decimal)
and/ or
-increase of the refractive astigmatism and/ or the spherical equivalent >= 1 diopter

Quellen:
[1]: Rabinowitz YS, Rasheed K. KISA% index: a quantitative videokeratography al-gorithm embodying minimal topographic criteria for diagnosing keratoconus. J Cat-aract Refract Surg 1999; 25(10): 1327-35.
[2]: Gomes JA, Rapuano CJ, Belin MW, et al. Global Consensus on Keratoconus Diagnosis. Cornea 2015; 34(12): e38-9.
[3]: Hashemi H, Seyedian MA, Miraftab M, et al. Corneal collagen cross-linking with riboflavin and ultraviolet a irradiation for keratoconus: long-term results. Ophthalmo-logy 2013; 120(8): 1515-20.

Exclusion Criteria

-previous ocular surgery
-previous ocular trauma
-stopp of contact lens wearing before the measurements <3 days (soft contact lenses) or < 5 days (hard contact lenses)
-unwillingness to participate in the study/ the necessary follow-up examinations.
-no written consent form (participation on the study)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of the visual - related quality of life Messung before and 6 month after the corneal collagen crosslinking in patients with progressive keratoconus.

Secondary Outcome Measures

Name	Time	Method
Visual acuity and corneal morphology changes before, 3 and 6 month after the therapy (See primary outcome)