Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma

NCT03548805 | Completed

• 1 other identifier: IIS-90616
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To the best of Investigator knowledge, no studies to this date have compared the safety and efficacyof ologen® Collagen Matrix to MMC in exaggerated healing response among JOAG patients. Given that,filtration surgery is usually less successful in patients with juvenile glaucoma; the purpose of this study is to compare these two adjuvant therapies in exaggerated healing response among JOAG patients. Investigator hypothesis is that trabeculectomy with ologen® Collagen Matrix would be as effective as MMC in IOP control, with prominent bleb morphology as compared to MMC bleb.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure control in the two groups will be compared.

  Comparison of IOP control between the two groups: Assess control of IOP over time. "Complete success" is defined as IOP reduction of \>20% and / or an IOP constantly \<21 mmHg without any antiglaucoma medication. "Qualified success" is defined as IOP \< 21 mmHg with topical antiglaucoma medication. "Failure" is defined as IOP \> 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication.

  1 year

Secondary Outcomes (1)

• Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time

  at 3 months, 6 months and 1 year

Study Arms (2)

Trabeculectomy with Ologen

EXPERIMENTAL

ologen® Collagen Matrix

Procedure: ologen® Collagen Matrix

Trabeculectomy with low dose mitomycin C

ACTIVE COMPARATOR

Trabeculectomy with low dose MMC (0.02%)

Procedure: Trabeculectomy with low dose mitomycin C

Interventions

ologen® Collagen Matrix PROCEDURE

Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs

Trabeculectomy with Ologen

Trabeculectomy with low dose mitomycin C PROCEDURE

Trabeculectomy with low dose MMC

Trabeculectomy with low dose mitomycin C

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 10 to 40 years (inclusive)
• Uncontrolled IOP (defined as IOP \> 21 mm Hg) despite maximum tolerable antiglaucoma therapy
• Open anterior chamber angle on gonioscopic examination
• Glaucomatous optic disc damage on clinical examination (focal or diffuse neuroretinal rim thinning, localized notching or nerve fiber layer defects) with corresponding visual field (VF) defects
• Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent

You may not qualify if:

• \. Patients with steroid-induced glaucoma and other types of secondary open angle glaucoma 2. Juvenile-onset Open Angle Glaucoma eyes that underwent trabeculectomy with MMC or had a previous filtering surgery 3. Patients with any other ocular disease that may expose them to an undue risk of a significant adverse event during the course of the study, including but not limited to ocular cancer, trauma, corneal surface damage or other conditions as determined by the clinical judgment of the investigator 4. Patient with single functional eye 5. Participation in any study 30 days prior to trabeculectomy 6. Pregnant or breast-feeding women

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead

Study Sites (1)

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy; Mitomycin

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Senthil Sirisha, MS

  YES

  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: Consultant-Ophthalmologist

Model Details: ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: June 7, 2018
• Study Start: August 16, 2018
• Primary Completion: April 1, 2023
• Study Completion: May 19, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)