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

Glaucoma Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648943
• Other study ID #: ES8/Th11/10-10-2013
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: November 30, 2016

Study information

• Verified date: November 2020
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 30, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye

Intervention

Procedure:
• Ex-Press mini shunt insertion

• Trabeculectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of corneal biomechanical properties	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	12 months
Secondary	Change of Intraocular Pressure	The Intraocular Pressure was measured with the Goldmann applanation tonometer before surgery and at 1, 6 and 12 months after surgery	12 months