Clinical Trials Directory

Trials / Completed

CompletedNCT04648943

The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties

The Effect of Antiglaucoma Procedures (Trabeculectomy vs. Ex-PRESS Glaucoma Drainage Implant) on the Corneal Biomechanical Properties

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Democritus University of Thrace · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma

Detailed description

The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy. The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF). The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups. The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREEx-Press mini shunt insertion
PROCEDURETrabeculectomy

Timeline

Start date
2013-07-01
Primary completion
2016-05-31
Completion
2016-11-30
First posted
2020-12-02
Last updated
2020-12-02

Source: ClinicalTrials.gov record NCT04648943. Inclusion in this directory is not an endorsement.