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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949347
• Other study ID #: NK003
• Status: Completed
• Start date: February 22, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2021
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Graft Failure
• Intraocular Pressure

Intervention

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.

Locations

Country	Name	City	State
Thailand	Naris Kitnarong	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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 — View Citation

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.00000000000002 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraocular pressure	The intraocular pressure level (must be less than 21 mmHg.)	preoperative and postoperative period from January 3, 2006 to August 31, 2019
Secondary	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
Secondary	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
Secondary	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