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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04949347
Enrollment
100
Registered
2021-07-02
Start date
2017-02-22
Completion date
2019-08-31
Last updated
2021-07-02

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

Conditions

Glaucoma, Graft Failure, Intraocular Pressure

Keywords

glaucoma, glaucoma surgery, patch graft, intraocular pressure

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.

Interventions

BIOLOGICALglaucoma drainage device implantation

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.

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Numbers of eyes with graft related complicationPostoperative period from January 3, 2006 to August 31, 2019Numbers of eyes with the patch-graft related complications included tube exposure, infection, leaking, etc

Secondary

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

Countries

Thailand

Outcome results

None listed

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