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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Graft Failure, Intraocular Pressure

Intervention / Treatment
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* Biological: glaucoma drainage device implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glycerin-preserved, human-donor, cornescleral patch grafts<br>Consecutive glaucoma patients who had undergone glaucoma drainage device implantation using glycerin-preserved, human-donor, cornescleral patch grafts | Biological: glaucoma drainage device implantation<br>* 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.<br>* Other names: glycerine-preserved corneoscleral patch graft;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, glaucoma surgery, patch graft, intraocular pressure