Glaucoma, Neovascular, Glaucoma, Open-Angle, Glaucoma Secondary
Conditions
Keywords
glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation
Brief summary
The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.
Detailed description
Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.
Interventions
PROCEDUREAhmed Glaucoma Valve surgery
The surgical procedure was identical for both implant types and was performed as described previously.9,14 All surgical procedures were performed under local anesthesia except for children, general anesthesia was used. The valve plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Coin test to choice the participants for both groups and reduce bias. Single surgeon ,highly expert in glaucoma to minimize unnecessary postoperative result changes.
Intervention model description
comparing clinical outcome variables (IOP, number of glaucoma medications, visual acuity, and complications) after using S2 and FP7 models of Ahmed Glaucoma Valves.
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery. 2. patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.
Exclusion criteria
1. patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits, 2. patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation. 3. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy. 4. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis. 5. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP . | one-year follow up | All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP . |
Outcome results
None listed