Evidence map›Paper›PMID 37208674›Full record

ArticleBMC ophthalmology2023

Efficacy of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus (C-CROSS study): study protocol for a randomized controlled trial.

Magali M S Vandevenne, Tos T J M Berendschot, Bjorn Winkens, Frank J H M van den Biggelaar, Nienke Visser, Mor M Dickman, Robert P L Wisse, Robert-Jan H J Wijdh, Abhijit Sinha Roy, Rohit Shetty and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.2field-weighted citation impact, top 8% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Observational
  3. Review
  4. Article
  5. Article
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

11 authors at 5 institutions in 2 countries.

Magali M S VandevenneUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands. magali.vandevenne@mumc.nl.
Tos T J M BerendschotUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands.
Bjorn WinkensDepartment of Methodology and Statistics, Faculty of Health, Medicine, and Life Sciences (FHML), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
Frank J H M van den BiggelaarUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands.
Nienke VisserUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands.
Mor M DickmanUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands.
Robert P L WisseOphthalmology Department, University Medical Centre Utrecht, Utrecht, the Netherlands.
Robert-Jan H J WijdhOphthalmology Department, University Medical Centre Groningen, Groningen, the Netherlands.
Abhijit Sinha RoyNarayana Nethralaya Eye Hospital, Bangalore, India.
Rohit ShettyNarayana Nethralaya Eye Hospital, Bangalore, India.
Rudy M M A NuijtsUniversity Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, Maastricht, 6229 HX, the Netherlands.
Maastricht University Medical Centre · NLNarayana Nethralaya · INMaastricht University · NLUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

ZonMw 116310006
6 · The paper itself

Abstract

backgroundKeratoconus is a degenerative disorder of the cornea leading to a protrusion and thinning with loss of visual acuity. The only treatment to halt the progression is corneal crosslinking (CXL), which uses riboflavin and UV-A light to stiffen the cornea. Recent ultra-structural examinations show that the disease is regional and does not affect the entire cornea. Treating only the affected zone with CXL could be as good as the standard CXL, that treats the entire cornea.

methodsWe set up a multicentre non-inferiority randomized controlled clinical trial comparing standard CXL (sCXL) and customized CXL (cCXL). Patients between 16 and 45 years old with progressive keratoconus were included. Progression is based on one or more of the following changes within 12 months: 1 dioptre (D) increase in keratometry (Kmax, K1, K2); or 10% decrease of corneal thickness; or 1 D increase in myopia or refractive astigmatism, requiring corneal crosslinking. DISCUSSION: The goal of this study is to evaluate whether the effectiveness of cCXL is non-inferior to sCXL in terms of flattening of the cornea and halting keratoconus progression. Treating only the affected zone could be beneficial for minimalizing the risk of damaging surrounding tissues and faster wound healing. Recent non-randomized studies suggest that a customized crosslinking protocol based on the tomography of the patient's cornea may stop the progression of keratoconus and result in flattening of the cornea.

trial registrationThis study was prospectively registered at ClinicalTrials.gov on August 31

Indexed as

KeratoconusPhotochemotherapyAdolescentAdultCollagenCorneaCorneal TopographyCross-Linking ReagentsEquivalence Trials as TopicHumansMiddle AgedMulticenter Studies as TopicPhotosensitizing AgentsRandomized Controlled Trials as TopicRefraction, OcularRiboflavinCollagenCross-Linking ReagentsPhotosensitizing AgentsRiboflavinCrosslinkingCustomizedKeratoconus

Identifiers

PMID37208674
PMCPMC10197381
OpenAlexW4377138857

What OpenQuestion holds

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Registered trials

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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.