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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030330
Enrollment
50
Registered
2022-10-04
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

H18.6

Interventions

Group 1: One arm only: before, 3 month and 6 month after corneal collagen crosslinking (Dresdner protocol
epi-off) for progressive keratoconus, the corneal morphology, visual acuity and visual-related quality of life parameters will be analyzed regarding potential changes.

Sponsors

Augenklinik des Universitätsklinikums Hamburg-Eppendorf (UKE)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Visual acuity and corneal morphology changes before, 3 and 6 month after the therapy (See primary outcome)

Countries

Germany

Contacts

Public ContactJohannes Steinberg

Augenklinik des Universitätsklinikums Hamburg-Eppendorf (UKE)

steinberg@zentrumsehstaerke.de+491759144115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026