Primary Open Angle GlaucomaNCT01301378
Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
A study testing Molteno 3 glaucoma drainage shunt in people with Primary Open Angle Glaucoma and Primary Angle Closure Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Molteno 3 glaucoma drainage shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2011
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
Who cannot join
- Age ≤ 18 years old.
- Any type of glaucoma other than those listed in the inclusion criteria.
- Less than 3 months of other ocular surgery.
- Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
- Patients with connective tissue disorder.
- Patients with congenital or developmental glaucoma.
Show all 14Show fewer
- Patients with severe dry eye syndrome.
- Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
- Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
- Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
- Patients with any prior history of allergy to the active compound.
- Pregnancy or breast-feeding.
- Patients enrolled in other prospective clinical trials.
- Patients that plan to use contact lens after surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
Read the detailed description
This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
- Conditions
- Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma, Traumatic Glaucoma, Uveitic Glaucoma
- Being tested
- Molteno 3 glaucoma drainage shunt
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Exfoliation Syndrome, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molteno 3 glaucoma drainage shuntProcedure or surgery
Also called Porcine Submucosal Tissue Patch Graft (Kerasys), Processed Pericardium Patch Graft (Tutoplast)
Patients needing glaucoma drainage surgery
| Study group | Role | What they receive |
|---|---|---|
| KeraSys Tissue Patch Graft | Active comparator | 20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft Receives: Procedure: Molteno 3 glaucoma drainage shunt |
| Tutoplast tissue patch graft | Active comparator | 20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft Receives: Procedure: Molteno 3 glaucoma drainage shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kerasys safety
The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.
Measured: one day, week one, 1 month, 3 month, 6 month, and 1 year
Secondary outcomes (1)
Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery
The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos.
Measured: 1 month, 3 month, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: kerasys had more erosions than tutoplast
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- IOP Ophthalmics
- Responsible party
- Principal investigator, Marlene Moster, MD, Wills Eye
- Investigators
- Marlene M Moster, MD, Principal investigator, Wills Eye Institute Glaucoma Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301378
- Sponsor's protocol ID
- 09-956 KeraSys
- Status last verified
- Nov 2016
- First submitted
- 22 Feb 2011
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49.
PubMed 18303385
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt
- ClinicalTrials.gov ID
- NCT01301378
- Acronym / sponsor ID
- 09-956 KeraSys
- Conditions
- Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma, Traumatic Glaucoma, Uveitic Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: kerasys had more erosions than tutoplast
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- IOP Ophthalmics
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Feb 2011 (estimated)
- 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.
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
Detailed description
This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KeraSys Tissue Patch Graft | Active comparator | Procedure: Molteno 3 glaucoma drainage shunt20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft |
| Tutoplast tissue patch graft | Active comparator | Procedure: Molteno 3 glaucoma drainage shunt20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
Key exclusion criteria (14 listed)
- Age ≤ 18 years old.
- Any type of glaucoma other than those listed in the inclusion criteria.
- Less than 3 months of other ocular surgery.
- Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
- Patients with connective tissue disorder.
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 |
|---|---|---|
| Molteno 3 glaucoma drainage shuntAlso: Porcine Submucosal Tissue Patch Graft (Kerasys), Processed Pericardium Patch Graft (Tutoplast)Patients needing glaucoma drainage surgery | Procedure or surgery | KeraSys Tissue Patch Graft, Tutoplast tissue patch graft |
Primary outcome
Kerasys safety
Time frame: one day, week one, 1 month, 3 month, 6 month, and 1 year
The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.
1 secondary outcome
Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery
Time frame: 1 month, 3 month, 6 month, 1 year
Results and safety
The study was stopped early (reason given: kerasys had more erosions than tutoplast). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 18303385Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49.
- 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.
Marlene M Moster, MD principal investigator
Wills Eye Institute Glaucoma Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molteno 3 glaucoma drainage shunt in people with Primary Open Angle Glaucoma and Primary Angle Closure Glaucoma, run by Wills Eye at 1 site in United States.
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 1 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Nov 2016. 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 United States. 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 was stopped early (reason given: kerasys had more erosions than tutoplast). Results are not available in the source record.
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?
Kerasys safety (time frame: one day, week one, 1 month, 3 month, 6 month, and 1 year). 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 NCT01301378, which also lists 1 linked publication.
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 22 Nov 2016.