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Completed

NCT Number: NCT04949347

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.

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Key information

Conditions

Glaucoma Eye Diseases Graft Failure Intraocular Pressure Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Naris Kitnarong

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glaucoma drainage device implantation

Biological

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

Primary outcomes

  1. 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 outcomes

  1. 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.)

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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