---
title: Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices
nct_id: NCT04949347
overall_status: COMPLETED
sponsor: Siriraj Hospital
study_type: OBSERVATIONAL
primary_condition: Glaucoma
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04949347.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04949347"
ct_last_update_post_date: 2021-07-02
last_seen_at: "2026-05-12T07:30:14.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

**NCT ID:** [NCT04949347](https://clinicaltrials.gov/study/NCT04949347)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Siriraj Hospital
- **Conditions:** Glaucoma, Graft Failure, Intraocular Pressure
- **Start Date:** 2017-02-22
- **Completion Date:** 2019-08-31
- **CT.gov Last Update:** 2021-07-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

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

## Interventions

- **glaucoma drainage device implantation** (BIOLOGICAL) — Glaucoma drainage device implantation, a 350 mm2 Baerveldt (BG 101-350) GDD (Johnson and Johnson, Santa Ana, CA, USA) was performed using glycerin-preserved, human-donor, corneoscleral tissue ( the remaining from a heterologous, human-donor corneal button, obtained from the International Eye Bank of Thailand, after a clear corneal graft had been used for penetrating keratoplasty.) The tissue had been preserved in glycerin using the sterile technique and kept in a medical refrigerator for no longer than 6 months.

## Primary Outcomes

- **Numbers of eyes with graft related complication** _(time frame: 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 Outcomes

- **Intraocular pressure** _(time frame: preoperative and postoperative period from January 3, 2006 to August 31, 2019)_
- **numbers of medication** _(time frame: Postoperative period from January 3, 2006 to August 31, 2019)_
- **Visual acuity** _(time frame: Postoperative period from January 3, 2006 to August 31, 2019)_
- **Numbers and types of post-operative intervention** _(time frame: Postoperative period from January 3, 2006 to August 31, 2019)_

## Locations (1)

- Naris Kitnarong, Bangkoknoi, Bangkok, Thailand

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.naris kitnarong|bangkoknoi|bangkok|thailand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04949347.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04949347*  
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