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

Democritus University of Thrace

Status: Completed

Conditions: Glaucoma Eye

Treatments: Procedure: Ex-Press mini shunt insertion; Procedure: Trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04648943

ES8/Th11/10-10-2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Patients undergoing Ex-Press mini shunt insertion

Active Comparator group

Description:

Patients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

Treatment:

Procedure: Ex-Press mini shunt insertion

Patients undergoing trabeculectomy

Active Comparator group

Description:

Patients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

Treatment:

Procedure: Trabeculectomy