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- Title
Treatment Effect and Corneal Light Scattering With 2 Corneal Cross-linking Protocols: A Randomized Clinical Trial.
- Authors
Rehnman, Jeannette Beckman; Lindén, Christina; Hallberg, Per; Behndig, Anders
- Abstract
<bold>Importance: </bold>We describe and evaluate a complementary method to indirectly quantify the treatment effect of corneal cross-linking (CXL). Additional methods to indirectly quantify the treatment effect of CXL are needed.<bold>Objective: </bold>To assess the spatial distribution and the time course of the increased corneal densitometry (corneal light backscatter) seen after CXL with riboflavin and UV-A irradiation.<bold>Design, Setting, and Participants: </bold>Open-label randomized clinical trial of 43 patients (60 eyes) who were 18 to 28 years of age and had progressive keratoconus and a plan to be treated with CXL at Umeå University Hospital, Umeå, Sweden. The patients were randomized to receive conventional CXL (n = 30) using the Dresden protocol or CXL with mechanical compression of the cornea using a flat rigid contact lens sutured to the cornea during the treatment (CRXL) (n = 30). All participants were followed up during a 6-month period from October 13, 2009, through May 31, 2012.<bold>Interventions: </bold>Corneal cross-linking according to the Dresden protocol or CRXL.<bold>Main Outcomes and Measures: </bold>Change in corneal densitometry after CXL and CRXL for keratoconus.<bold>Results: </bold>Of the original 60 eyes included, 4 had incomplete data. A densitometry increase was seen after both treatments that was deeper and more pronounced in the CXL group (difference between the groups at 1 month in the center layer, zone 0-2 mm, 5.02 grayscale units [GSU], 95% CI, 2.92-7.12 GSU; P < .001). This increase diminished with time but was still noticeable at 6 months (difference between the groups at 6 months in the center layer, zone 0-2 mm, 3.47 GSU; 95% CI, 1.72-5.23 GSU; P < .001) and was proportional to the reduction in corneal steepness (R = -0.45 and -0.56 for CXL and CRXL, respectively).<bold>Conclusions and Relevance: </bold>The degree of corneal light backscatter relates to the reduction in corneal steepness after cross-linking and may become a relevant complement to other methods in evaluating the cross-linking effect, for example, when comparing different treatment regimens.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT02425150.
- Subjects
CORNEA physiology; SCATTERING (Physics); VITAMIN B2; COLLAGEN; RESEARCH; CONFIDENCE intervals; CORNEA diseases; PHOTOSENSITIZERS; RESEARCH methodology; CORNEAL cross-linking; CHEMICAL reagents; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; RANDOMIZED controlled trials; DENSITOMETRY; LIGHT; CORNEA; ULTRAVIOLET radiation; PROBABILITY theory; METABOLISM
- Publication
JAMA Ophthalmology, 2015, Vol 133, Issue 11, p1254
- ISSN
2168-6165
- Publication type
journal article
- DOI
10.1001/jamaophthalmol.2015.2852