NCT01301378

Brief Summary

The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

February 22, 2011

Last Update Submit

November 20, 2016

Conditions

Primary Open Angle GlaucomaPrimary Angle Closure GlaucomaPseudoexfoliation GlaucomaPigmentary GlaucomaTraumatic GlaucomaUveitic GlaucomaNeovascular Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Kerasys safety

    The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.

    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

    1 month, 3 month, 6 month, 1 year

Study Arms (2)

KeraSys Tissue Patch Graft

ACTIVE COMPARATOR

20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft

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

Procedure: Molteno 3 glaucoma drainage shunt

Interventions

Molteno 3 glaucoma drainage shuntPROCEDURE

Patients needing glaucoma drainage surgery

Also known as: Porcine Submucosal Tissue Patch Graft (Kerasys), Processed Pericardium Patch Graft (Tutoplast)
KeraSys Tissue Patch GraftTutoplast tissue patch graft

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma

You may not qualify if:

  • Age ≤ 18 years old.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 18303385BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma, Angle-ClosureExfoliation SyndromeGlaucoma, Neovascular

Interventions

Tutoplast

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Study Officials

  • Marlene M Moster, MD

    Wills Eye Institute Glaucoma Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marlene Moster, MD Principal Investigator, Wills Eye Institute Glaucoma Department

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)