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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Intraocular Pressure; Graft Failure
• Intervention / Treatment: Biological: glaucoma drainage device implantation

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Naris Kitnarong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Biological: glaucoma 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.; Other Names: glycerine-preserved corneoscleral patch graft

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Publications and helpful links

General Publications

• Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
• Tsoukanas D, Xanthopoulou P, Charonis AC, Theodossiadis P, Kopsinis G, Filippopoulos T. Heterologous, Fresh, Human Donor Sclera as Patch Graft Material in Glaucoma Drainage Device Surgery. J Glaucoma. 2016 Jul;25(7):558-64. doi: 10.1097/IJG.0000000000000294.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: intraocular pressure; glaucoma; glaucoma surgery; patch graft
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: NK003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No