NCT01912638

Brief Summary

The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

July 1, 2015

Enrollment Period

4.2 years

First QC Date

July 29, 2013

Last Update Submit

September 20, 2016

Conditions

Steroid Induced Glaucoma

Keywords

TrabeculectomyGlaucomaSteroidsOlogenViscoelastic

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications. Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.

    2 years

Secondary Outcomes (3)

  • Postoperative complications

    2 years

  • Corrected distance visual acuity (CDVA)

    2 years

  • Appearance of the filtering bleb (FB)

    2 years

Study Arms (2)

Implantation of Ologen in trabeculectomy

EXPERIMENTAL

Ologen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space.

Device: Ologen Collagen Matrix

Provisc in trabeculectomy

ACTIVE COMPARATOR

Provisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony.

Drug: Provisc

Interventions

Ologen Collagen MatrixDEVICE

Ologen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed.

Implantation of Ologen in trabeculectomy
ProviscDRUG

Provisc is an cohesive viscoelastic.

Provisc in trabeculectomy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 16 years (inclusive)
  • Patients with medically uncontrolled steroid induced glaucoma

You may not qualify if:

  • Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
  • Known allergic reaction to porcine collagen
  • Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Centre of Ophthalmology named after academician Zarifa Aliyeva

Baku, AZ1114, Azerbaijan

Location

Related Publications (1)

  • Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

    PMID: 36912740DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Elmar Kasimov, Professor

    Director of National Centre of Ophthalmology

    STUDY DIRECTOR

  • Fidan Aghayeva, MD

    Glaucoma consultant at National Centre of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

July 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 21, 2016

Record last verified: 2015-07

Locations

AZ(1)