Keratoconus Characteristics Used in Randomized Trials of Surgical Interventions-A Systematic Review

Purpose:To investigate descriptions and inclusion criteria of keratoconus used in randomized trials assessing the efficacy of surgical and nonsurgical interventions.Methods:Systematic review: we searched (Pre-)Medline and the Cochrane Library from inception until December 2018 and checked the reference lists of included articles and reviews. We included randomized trials assessing the efficacy of any kind of keratoconus treatment. No language restrictions were imposed. We assessed articles against the inclusion criteria, extracted relevant data including any kind of keratoconus description, and examined the methodological quality.Results:Searches retrieved 459 nonduplicate records, and we included 57 randomized controlled trials investigating 9 different surgical interventions with the most used primary outcome measure being maximum keratometry. Only 15 (26.3%) described eligibility parameters regarding keratoconus staging/classification, of which 12 studies used the Amsler-Krumeich classification. Eleven studies were published before 1997 (before publication of the Consolidated Standards of Reporting Trials statement), and none of these described the use of a classification. From 1997 onward, 15 of 46 studies (32.6%) described the incorporation of a classification system (P = 0.051). The average methodological quality of included trails was modest.Conclusions:The evidence from randomized trials, even after introduction of the Consolidated Standards of Reporting Trials statement, remains ill-formed regarding a careful definition of keratoconus. This is unfortunate because imprecisions regarding the specification of included patients preclude clinicians to assess applicability, that is, the extent to which they can use inferences drawn from study participants regarding efficacy and adverse events in the care of individual patients.