An observational study in Glaucoma, Graft Failure and Intraocular Pressure, sponsored by Siriraj Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by Siriraj Hospital · Observational
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.
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.
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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).
Exclusion Criteria:
1.Patients who had follow-up period less than 12 months after operation.
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.
Also known as: glycerine-preserved corneoscleral patch graft
Numbers of eyes with graft related complication
Numbers of eyes with the patch-graft related complications included tube exposure, infection, leaking, etc
Time frame: Postoperative period from January 3, 2006 to August 31, 2019
Intraocular pressure
The intraocular pressure level (must be less than 21 mmHg.)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Postoperative period from January 3, 2006 to August 31, 2019
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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