The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties
NCT ID: NCT04648943
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2013-07-01
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients undergoing Ex-Press mini shunt insertion
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
Ex-Press mini shunt insertion
Patients undergoing trabeculectomy
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
Trabeculectomy
Interventions
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Ex-Press mini shunt insertion
Trabeculectomy
Eligibility Criteria
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Inclusion Criteria
* Average Intraocular pressure \> 24 mmHg on at least 2 occasions 1 month before surgery
* Congenital glaucoma
Exclusion Criteria
* Previous ocular surgery other than phacoemulsification
* Previous disease of the ocular surface
18 Years
ALL
No
Sponsors
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Democritus University of Thrace
OTHER
Responsible Party
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Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Principal Investigators
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Georgios Labiris, MD, PhD
Role: STUDY_CHAIR
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Other Identifiers
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ES8/Th11/10-10-2013
Identifier Type: -
Identifier Source: org_study_id