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Completed

NCT Number: NCT04648943

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

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

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Key information

Conditions

Glaucoma Eye Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ex-Press mini shunt insertion

Procedure

trabeculectomy

Procedure

Primary outcomes

  1. Change of corneal biomechanical properties

    Time frame: 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 outcomes

  1. Change of Intraocular Pressure

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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