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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma Eye

Intervention / Treatment
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* Procedure: Ex-Press mini shunt insertion
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients undergoing Ex-Press mini shunt insertion<br>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 | Procedure: Ex-Press mini shunt insertion<br> <br> |
| Active Comparator: Patients undergoing trabeculectomy<br>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 | Procedure: Trabeculectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor