Clinical trial NCT04949347: Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices
Official title: Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Graft Failure
Intraocular Pressure
Keywords: glaucoma
glaucoma surgery
patch graft
intraocular pressure
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numbers of eyes with graft related complication
timeFrame: Postoperative period from January 3, 2006 to August 31, 2019
Secondary outcomes:
measure: Intraocular pressure
timeFrame: preoperative and postoperative period from January 3, 2006 to August 31, 2019
measure: numbers of medication
timeFrame: Postoperative period from January 3, 2006 to August 31, 2019
measure: Visual acuity
timeFrame: Postoperative period from January 3, 2006 to August 31, 2019
measure: Numbers and types of post-operative intervention
timeFrame: Postoperative period from January 3, 2006 to August 31, 2019
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Naris Kitnarong
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Naris Kitnarong, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
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.0000000000000294.
citation: 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.