GlaucomaNCT04949347
Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices
An observational study of Glaucoma and Graft Failure, run by Siriraj Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Graft Failure, Intraocular Pressure
- What is being tested?
- glaucoma drainage device implantation
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 22 Feb 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 1.Patients who had follow-up period less than 12 months after operation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glaucoma, Graft Failure, Intraocular Pressure
- Being tested
- glaucoma drainage device implantation
- Keywords
- glaucoma, glaucoma surgery, patch graft, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glaucoma drainage device implantationBiological
Also called glycerine-preserved corneoscleral patch graft
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: glaucoma drainage device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of eyes with graft related complication
Numbers of eyes with the patch-graft related complications included tube exposure, infection, leaking, etc
Measured: Postoperative period from January 3, 2006 to August 31, 2019
Secondary outcomes (4)
Intraocular pressure
The intraocular pressure level (must be less than 21 mmHg.)
Measured: 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
Measured: 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
Measured: 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
Measured: Postoperative period from January 3, 2006 to August 31, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start22 Feb 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naris Kitnarong, Siriraj Hospital
- Investigators
- Naris Kitnarong, M.D., M.B.A., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949347
- Sponsor's protocol ID
- NK003
- Status last verified
- Jun 2021
- First submitted
- 30 Sep 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26091179Gedde 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.
PubMed 29477688
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices
- ClinicalTrials.gov ID
- NCT04949347
- Acronym / sponsor ID
- NK003
- Conditions
- Glaucoma, Graft Failure, Intraocular Pressure
- Keywords
- glaucoma, glaucoma surgery, patch graft, intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycerin-preserved, human-donor, cornescleral patch grafts | – | Biological: glaucoma drainage device implantationConsecutive glaucoma patients who had undergone glaucoma drainage device implantation using glycerin-preserved, human-donor, cornescleral patch grafts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 1.Patients who had follow-up period less than 12 months after operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glaucoma drainage device implantationAlso: glycerine-preserved corneoscleral patch graftGlaucoma 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. | Biological | Glycerin-preserved, human-donor, cornescleral patch grafts |
Primary outcome
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
4 secondary outcomes
Intraocular pressure
Time frame: preoperative and postoperative period from January 3, 2006 to August 31, 2019
numbers of medication
Time frame: Postoperative period from January 3, 2006 to August 31, 2019
Visual acuity
Time frame: Postoperative period from January 3, 2006 to August 31, 2019
Numbers and types of post-operative intervention
Time frame: Postoperative period from January 3, 2006 to August 31, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Results publication: PubMed 26091179Tsoukanas 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.
- Results publication: PubMed 29477688Gedde 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naris Kitnarong, M.D., M.B.A. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Graft Failure, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of eyes with graft related complication (time frame: Postoperative period from January 3, 2006 to August 31, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.