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

Not Applicable

Completed

• Conditions: Glaucoma Eye

• Registration Number: NCT04648943
• Lead Sponsor: Democritus University of Thrace

Brief 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.

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2016-05-31
• Study Completion: 2016-11-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-21
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Age > 18
• Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery
• Congenital glaucoma

Exclusion Criteria

• Previous ocular trauma
• Previous ocular surgery other than phacoemulsification
• Previous disease of the ocular surface

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of corneal biomechanical properties	12 months	Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH).; These two indicators were measured before surgery and at 1, 6 and 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Change of Intraocular Pressure	12 months	The Intraocular Pressure was measured with the Goldmann applanation tonometer before surgery and at 1, 6 and 12 months after surgery