Open-angle Glaucoma
Conditions
Keywords
ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery
Brief summary
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
Detailed description
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created. The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
Interventions
DEVICEUse of ologen Collagen Matrix in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
DRUGUse of Mitomycin-C in trabeculectomy
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
Sponsors
Aeon Astron Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or over * Uncontrolled open-angle glaucoma * Subject is willing to sign informed consent * Subject is able and willing to complete post-operative follow-up requirements
Exclusion criteria
* Inflammatory eye diseases * Angle-closure glaucoma * Secondary glaucoma with anatomical malformations of the eye * Subjects having single functional eye * Previous conjunctival surgery * Known allergic reactions to ingredients of ologen Collagen Matrix * Excessive myopia (axial length (AL)\> 27 mm or more than -10 diopters) * Previous vitrectomy eye surgery * Subjects do not consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure (IOP) reduction | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complications | 6 months |
Countries
Germany
Contacts
Primary ContactThomas Dietlein, MD
Outcome results
None listed