Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

Completed

• Conditions: Glaucoma; Intraocular Pressure; Graft Failure
• Interventions: Biological: glaucoma drainage device implantation

• Registration Number: NCT04949347
• Lead Sponsor: Siriraj Hospital

Brief Summary

This was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (Baerveldt shunt) during January 2006 to December 2016. Glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the GDD over the sclera. The patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

Detailed Description

This retrospective, non-comparative study was conducted at the Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The medical records of consecutive patients who had undergone glaucoma drainage device implantation employing the fornix-based conjunctival flap technique and using a glycerin-preserved, human-donor, corneoscleral graft. The procedures were carried out by, or under the supervision of, one surgeon (NK) between January 2006 and December 2016 were reviewed. The study protocol was approved by the Siriraj Institutional Review Board, Faculty of Medicine, Siriraj Hospital, Mahidol University.

Study Timeline

• Study Start: 2017-02-22
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Study First Submitted: 2019-09-30
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Consecutive patients who had undergone glaucoma drainage device implantations between January 2006 and December 2016 at Siriraj hospital by or under supervision of one surgeon (NK).
2. The GDD implantation using glycerin-preserved, human-donor, corneoscleral tissue as a patch graft

Exclusion Criteria

1.Patients who had follow-up period less than 12 months after operation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glycerin-preserved, human-donor, cornescleral patch grafts	glaucoma drainage device implantation	Consecutive glaucoma patients who had undergone glaucoma drainage device implantation using glycerin-preserved, human-donor, cornescleral patch grafts

Primary Outcome Measures

Name	Time	Method
Numbers of eyes with graft related complication	Postoperative period from January 3, 2006 to August 31, 2019	Numbers of eyes with the patch-graft related complications included tube exposure, infection, leaking, etc

Secondary Outcome Measures

Name	Time	Method
numbers of medication	Postoperative period from January 3, 2006 to August 31, 2019	Numbers of post-operative anti-glaucoma medication comparing to pre-operative medications
Visual acuity	Postoperative period from January 3, 2006 to August 31, 2019	The level of post-operative visual acuity compared to pre-operative visual acuity
Intraocular pressure	preoperative and postoperative period from January 3, 2006 to August 31, 2019	The intraocular pressure level (must be less than 21 mmHg.)
Numbers and types of post-operative intervention	Postoperative period from January 3, 2006 to August 31, 2019	Numbers and types of post-operative intervention to correct the complication

Trial Locations

Locations (1)

Naris Kitnarong; 🇹🇭 Bangkoknoi, Bangkok, Thailand