Evidence map›Paper›PMID 35431539›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2022

The Safety Profile of FDA-Approved Epithelium-Off Corneal Cross-Linking in a US Community-Based Healthcare System.

Michael J Ang, Jeanne A Darbinian, Eliza N Hoskins, Douglas S Holsclaw, Sudha Sudesh, Naveen S Chandra

Abstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Michael J AngDepartment of Ophthalmology, California Pacific Medical Center, San Francisco, CA, USA.
Jeanne A DarbinianDivision of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
Eliza N HoskinsDepartment of Ophthalmology, The Permanente Medical Group, Oakland, CA, USA.
Douglas S HolsclawDepartment of Ophthalmology, The Permanente Medical Group, Oakland, CA, USA.
Sudha SudeshDepartment of Ophthalmology, The Permanente Medical Group, Oakland, CA, USA.
Naveen S ChandraDepartment of Ophthalmology, The Permanente Medical Group, Oakland, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To determine the occurrence of early post-operative complications following FDA-approved epithelium-off corneal cross-linking in the United States. Materials and Methods: This multicenter, retrospective cohort study identified patients who underwent epithelium-off (epi-off) corneal cross-linking (CXL) for keratoconus and post-refractive keratectasia within the Kaiser Permanente Northern California healthcare system between 2016 and 2018. Post-operative complications including delayed epithelial healing, infection, and loss of visual acuity were recorded. Results: The study included 878 eyes of 654 patients. The mean age was 27±9.4 years (range 7-71). Five hundred ninety-nine patients (91.6%) had keratoconus while 55 had post-refractive corneal ectasia (8.4%). Forty-seven eyes had prolonged follow-up because of the occurrence of complications in the early post-operative period. The respective rates of delayed epithelial healing, and keratitis were 3.9% (95% CI 2.7-5.3%), and 1.5% (95% CI 0.8-2.5%). Four approaches for management of delayed epithelial healing were compared; epithelium healing duration was the longest in the repeat bandage contact lens (BCL) group (23.8 days) and the shortest in the antibiotic ointment group (14.3 days), with statistically significant differences (p < 0.05) in the healing time between these 2 groups. Conclusion: The concern for early clinical complications after epi-off CXL often leads to delayed CXL intervention and further keratoconus progression with increased economic burdens. A large retrospective review of 878 eyes found that FDA-approved epi-off CXL protocol appears to be safe with low occurrence rates of early post-operative complications. The recommended management for delayed epithelial healing is using antibiotic ophthalmic ointment.

Indexed as

corneal cross-linkingCXLepithelial healingepithelium-offkeratoconuspost-operative complications

Identifiers

PMID35431539
PMCPMC9012302

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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.