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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04648943

Enrollment

Registered

2020-12-02

Start date

2013-07-01

Completion date

2016-11-30

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye

Keywords

glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor

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.

Interventions

PROCEDUREEx-Press mini shunt insertion

PROCEDURETrabeculectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026