Glaucoma
Conditions
Keywords
ologen collagen matrix, mitomycin-C, trabeculectomy, glaucoma, filtering surgery
Brief summary
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.
Detailed description
ologen ® CM is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study. Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile. The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.
Interventions
DEVICEUse of ologen Collagen Matrix in trabeculectomy (ologen)
Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
DRUGUse of Mitomycin-C (MMC) in trabeculectomy
After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.
Sponsors
The New York Eye & Ear Infirmary
Robert Ritch, MD, LLC.
Aeon Astron Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 30 years (inclusive) * Uncontrolled treated glaucoma requiring trabeculectomy * Subject must be able and willing to cooperate with investigation plan * Subject must be able and willing to complete postoperative follow-up requirements * subject must be willing to sign informed consent form
Exclusion criteria
* Known allergic reaction to MMC or porcine collagen * Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery * Prior cataract unless clear corneal incision * Previous conjunctival or strabismus surgery * Participation in an investigational study during 30 days prior to trabeculectomy * Ocular infection within 14 days prior to trabeculectomy * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure(IOP) reduction | At postoperative up to 24 months. | Complete success is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP. Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size. Qualified success that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and Failure of meeting the IOP requirements are the other efficacy parameters. In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications and appearances | At postoperative up to 24 months. | Inspections of hyphema, severe anterior chamber reaction, hypotony, supercholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak. Visual acuity, bleb appearance, and anterior chamber inflammation. |
Countries
United States
Outcome results
None listed