NCT Number: NCT04215575
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in refractory glaucoma cases in order to compare it with the Ahmed implant.
Looking for future studies?
Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of Baerveldt implant or Ahmed implant models using a standardized surgical technique.
The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1 - patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
2- patients who had secondary glaucoma and are known to have a high failure rate with trabeculectomy such as neovascular, uveitis, or iridocorneal endothelial syndrome-associated glaucoma, were included in the study.
Exclusion criteria
1 - patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
2-had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
3- presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
4-uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
A 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
Other names: glaucoma valve surgery
A 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
Other names: glaucoma valve surgery
Time frame: one year follow up
mean IOPs
Time frame: one year follow up
mean number of glaucoma medications
Time frame: one year follow up
log MAR Snellen median and interquartile Range values
Ain Shams University
Other
Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03187418
Eye Diseases, Glaucoma
Montreal, Quebec, Canada
View Trial DetailsNCT04602923
Eye Diseases, Glaucoma
Montreal, Quebec, Canada
View Trial DetailsNCT04214847
Eye Diseases, Glaucoma
View Trial DetailsNCT02959242
Eye Diseases, Glaucoma
Dresden, Saxony, Germany
View Trial Details