Evidence map›Paper›PMID 25050368›Full record

Trial reportBioMed research international2014

Corneal collagen cross-linking with and without epithelial removal: a contralateral study with 0.5% hypotonic riboflavin solution.

Aleksandar Stojanovic, Wen Zhou, Tor Paaske Utheim

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BioMed research international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01181219 (Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01181219 phase2completednot on this map

Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning

TypeinterventionalSponsorUniversity Hospital of North NorwayRan2010 to 2014Enrolled20ConditionsKeratoconusArmsCXL without epithelial removal, CXL with epithelial removal
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Epithelium-on versus epithelium-off corneal collagen crosslinking for keratoconus: a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Review
  11. Squishy matters - Corneal mechanobiology in health and disease.Progress in retinal and eye research · 2024
    Review
  12. Article
  13. Article
  14. Article
  15. Complications of corneal collagen cross-linking.Indian journal of ophthalmology · 2022
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Current concepts in crosslinking thin corneas.Indian journal of ophthalmology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Aleksandar StojanovicSynsLaser Kirurgi AS, 9007 Tromsø, Troms, Norway ; Eye Department, University Hospital North Norway, Sykehusveien 38, 9019 Tromsø, Troms, Norway.ORCID 0000-0003-1363-4689
Wen ZhouSynsLaser Kirurgi AS, 9007 Tromsø, Troms, Norway.ORCID 0000-0001-8128-5797
Tor Paaske UtheimDepartment of Medical Biochemistry, Oslo University Hospital, 0450 Oslo, Norway.ORCID 0000-0002-3821-6777

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOur main purpose was to compare safety and efficacy in the treatment of progressive keratoconus with "epithelium-on" and "epithelium-off" corneal collagen cross-linking (CXL). Our secondary purpose was to evaluate efficacy of CXL when hypotonic 0.5% riboflavin is used as photosensitizer.

methodsOne eye of 20 patients with bilateral progressive keratoconus was randomly treated for "epithelium-on" CXL (group 1) while the fellow eye underwent "epithelium-off" CXL (group 2). Hypotonic 0.5% riboflavin was used in both groups. Visual acuity, refraction, corneal topography, and wavefront aberrometry were evaluated at baseline and after 1, 6, and 12 months. Specular microscopy was performed on 10 patients preoperatively and after 12 months. Postoperative pain was evaluated using a patient questionnaire.

resultsUncorrected and corrected distance visual acuity improved significantly in both groups. Refraction, topography, and aberrometry showed nonsignificant changes from the preoperative status throughout the 12-month follow-up in both groups. Moreover, the outcomes between the groups were comparable at all follow-up points. Endothelial cell-count was stable. Postoperative pain length was shorter in group 1 (P < 0.001).

conclusion"Epithelium-on" and "epithelium-off" CXL using hypotonic 0.5% riboflavin were equally safe and effective in stabilization of keratoconus. Topography and aberrometry outcomes in both groups failed to show any significant improvements. This study is registered at ClinicalTrials.gov: NCT01181219.

Indexed as

AdultCollagenCorneal PachymetryCorneal TopographyCross-Linking ReagentsEpithelium, CornealFemaleFollow-Up StudiesHumansHypotonic SolutionsMaleMiddle AgedRefraction, OcularRiboflavinVisual AcuityYoung AdultCollagenCross-Linking ReagentsHypotonic SolutionsRiboflavin

Identifiers

PMID25050368
PMCPMC4090564

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.