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Brittney Statler, Taygan Yilmaz, Kimberly Miller, Michael Migliori; Cataract-related Interventional Clinical Trials Analysis. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4793. doi: https://doi.org/.
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Globally, a multitude of interventional clinical trials for the treatment of cataracts have been performed, especially in the past decade. We sought to identify and analyze trends related to the reporting of these trial results.
We conducted a retrospective, cross-sectional study of cataract-based, interventional clinical trials in ClinicalTrials.gov dating back to 1982. Data were collected from the registry and the final search was conducted on October 30, 2017. The data that were analyzed included type of study, trial phase, enrollment, and funding sources.
There was more than a four-fold increase in the number of trials performed during the period of 2007-2017 when compared to previous decades. A total of 386 studies were reviewed, of which 220 (57%) were industry-sponsored. 49% of trials were performed in either phase 3 or 4 settings. The included trials employed interventions such as devices/procedures (n=233; 60%), peri-operative or novel drugs (n=140; 36%), and other (n=13; 4%). Of the 351 completed trials, 310 (88%) were not published, which represents a total of 50,917 participants who incurred the risks of trial participation without subsequently contributing to the medical literature. 35 (9%) were discontinued prematurely and only one study’s results were published, which represents a total of 1,535 participants. Only 30% (n=93) of unpublished trials posted results on ClinicalTrials.gov. Of the 386 trials examined, 49 publications from 41 trials were identified via PubMed/MEDLINE and EMBASE searches. Over 65% of the reasons for trial discontinuation were due to conduct problems (technical or logistical issues), company/business decisions, or unspecified/unclear reasons. Notably, trials funded by industry were more than twice as likely as trials funded by academic centers to result in non-publication (OR 2.16, 95% CI 1.11 - 4.21, p =0.02).
There has been a remarkable upsurge in cataract-related research during the last decade. However, further action is warranted to ensure trial findings are shared with the ophthalmic community in an attempt to build comprehensive knowledge and decrease potential redundancy. Publication of inconclusive or negative results also ensures that the contributions of study participants are honored.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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