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

NCT ID: NCT03548805

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2023-05-19

Brief Summary

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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.

Detailed Description

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Standard trabeculectomy All trabeculectomy surgeries will be performed under peribulbar anesthesia.Under aseptic surgical technique, superior rectus suture will be placed using 4-0 silk and a fornix-based conjunctival flap will be performed. Sub-Tenon dissection and hemostasis may be performed as required.A half-thickness 4 x 4mm rectangular/ triangular scleral flap will be dissected up to clear cornea, and a 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one or two 10-0 nylon sutures and conjunctiva will be closed with 8-0 vicryl suture. Releasable sutures may be applied to the scleral flap if needed.

ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.

The following table summarizes the model number, shape and manufacturer of ologen® Collagen Matrix to be used in this clinical research.

Product Model Shape Size Manufacturer Country of Origin Product Registration ologen® Collagen Matrix 830601 Round cylindrical 6mm (diameter) x 2mm (thickness) Aeon Astron Europe B. V. The Netherlands MD-1517 (valid till Mar-15-2018)

Mitomycin C Mitomycin-C Kyowa®; Kyowa Hakko Kogyo Co., Ltd. will be used. 0.02% solution of MMC will be prepared freshly on the day of planned surgery.

Conditions

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Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trabeculectomy with Ologen

ologen® Collagen Matrix

Group Type EXPERIMENTAL

ologen® Collagen Matrix

Intervention Type PROCEDURE

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

Trabeculectomy with low dose mitomycin C

Trabeculectomy with low dose MMC (0.02%)

Group Type ACTIVE_COMPARATOR

Trabeculectomy with low dose mitomycin C

Intervention Type PROCEDURE

Trabeculectomy with low dose MMC

Interventions

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ologen® Collagen Matrix

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

Intervention Type PROCEDURE

Trabeculectomy with low dose mitomycin C

Trabeculectomy with low dose MMC

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age between 10 to 40 years (inclusive)
2. Uncontrolled IOP (defined as IOP \> 21 mm Hg) despite maximum tolerable antiglaucoma therapy
3. Open anterior chamber angle on gonioscopic examination
4. 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
5. Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria

1\. 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

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Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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L.V. Prasad Eye Institute

OTHER

Sponsor Role lead

Responsible Party

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HERF

Consultant-Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Senthil Sirisha, MS

Role: PRINCIPAL_INVESTIGATOR

YES

Locations

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L V Prasad Eye Institute

Hyderabad, Telangana, India

Site Status

Countries

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India

Other Identifiers

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IIS-90616

Identifier Type: -

Identifier Source: org_study_id