MedTrace Logo

Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome

NCT04735601 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-06

No results posted yet for this study

Summary

Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral venous raised pressure.(2-3) Glaucoma associated with Sturge weber syndrome is difficult to be treated medically with high risk of complications when treated with bleb -based surgeries. Suprachoroidal hemorrhage or detachment is a challenging complication which must be encountered.

The usage of Ahmed valve in the management of glaucoma associated with Sturge weber syndrome is a bleb based procedure carries the risks of over filtration or encapsulation and decreased filtration with failure to control glaucoma.

The use of Ahmed valve in the management of pediatric glaucoma associated with Sturge weber syndrome has better results as recorded by Nassiri et al. Ahmed valve implantation can have some drawbacks such as pupillary irregularity, lens opacification, or encapsulation.(4-7) Glaucoma drainage devices such as Ahmed valve, Molteno or Braeveldt valve can be used when other methods of treatment fail, they provide alternative pathway to the aqueous to be collected in a plate positioned under the conjunctiva, (8-10) Encapsulation is a major problem occurs around the end plate due to fibrous reaction and so the drainage of the aqueous is decreased , Epatein (11) attributed that to fibro vascular proliferation in the episcleral tissue .the fibrous reaction is multifactorial , it may be due to the size of the end plate, the biomaterial, design or the shape of the plate.

The use of drainage devices with advanced drug delivery system can improve the success of drainage device.

A double-layered porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA) was described by Ponnusamy et al. \[12\] to produce continuous release of antifibrotic agents \[mitomycin C (MMC) and/or 5-fluorouracil (5-FU)\] to the subconjunctival space. This release continue for about one month with decreasing fibrosis, the nanofiltration membrane could entrap the proteins passing out from the anterior chamber leading to minimal increase in aqueous resistance.(12-13)

Conditions

Interventions

PROCEDURE

Ahmed Valve

Ahmed valve implantation coated with poly lactic -co-glycolic acid (PLGA) saturated with Mitomycin-C in the management of adult onset glaucoma in Sturge Weber syndrome

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Hany Mahmoud, MD · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-12-15
Completion
2022-12-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735601 on ClinicalTrials.gov