Konstantinidis 2021.
| Methods |
Study design: prospective comparative study (unclear randomization), single center Country: Greece Number analyzed: 30 eyes of 30 participants total; 19 for in trabeculectomy + Ex‐PRESS mini shunt group and 11 for trabeculectomy group Losses to follow‐up: 0 eyes of 0 participants total; 0 for in trabeculectomy + Ex‐PRESS mini shunt group and 0 for trabeculectomy group Unit of analysis: eye How were missing data handled? not reported Power calculation: "The power of all statistical tests used was greater than 0.8, suggesting that the size of our sample was sufficient (G*Power 3.1.9.2, University of Dusseldorf, Dusseldorf, Germany)" |
| Participants |
Age Range 16–81 (mean 62.4) years for trabeculectomy + Ex‐PRESS mini shunt group; Range 60–78 (mean 67.2) years for trabeculectomy group Gender 10/19 (53%) men and 9/19 (47%) women in trabeculectomy + Ex‐PRESS mini shunt group; 6/11 (55%) men and 5/11 (54%) women in trabeculectomy group Inclusion criteria: not reported Exclusion criteria: previous ocular trauma, ocular surgery other than phacoemulsification, previous disease of the ocular surface, and congenital glaucoma Equivalence of baseline characteristics: yes |
| Interventions |
Intervention 1: trabeculectomy + Ex‐PRESS mini shunt Intervention 2: trabeculectomy Length of follow‐up Planned: 1, 6, and 12 months Actual: 1, 6, and 12 months |
| Outcomes |
Primary outcomes, as defined: corneal resistance factor and corneal hysteresis measured using the Ocular Response Analyzer Secondary outcomes, as defined: IOP measured with the Goldmann Applanation Tonometry Intervals at which outcomes assessed: 1, 6, and 12 months |
| Notes |
Publication type: published article Funding sources: none Disclosures of interest: authors declared that they had no conflicts of interest Trial registry: not reported Study period: July 2013 to May 2016 Subgroup analyses: none reported Publication language: English |
IOP: intraocular pressure.