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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 31, 2019

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

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Siriraj Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Naris Kitnarong, Associate professor – Siriraj Hospital
  • Overall Official(s)
    • Naris Kitnarong, M.D., M.B.A., Principal Investigator, Mahidol University

Citations Reporting on Results

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.

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.

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