Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases

NCT04215575 | Completed DMC

• 1 other identifier: FWA000017585 FMASU21/2017
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Neovascular; Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (2)

• IOP

  mean IOPs

  one year follow up

• glaucoma medications

  mean number of glaucoma medications

  one year follow up

Secondary Outcomes (1)

• visual acuity

  one year follow up

Study Arms (2)

BGI model 101-350 placement (BGI group)

ACTIVE COMPARATOR

A 350 mm2 Baerveldt glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.

Device: glaucoma implant procedure (Baerveldt)

AGV model FP7 or S2 placement (AGV group)

EXPERIMENTAL

A 184 mm2 Ahmed glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits. The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures

Device: glaucoma implant procedure (Ahmed)

Interventions

glaucoma implant procedure (Baerveldt) DEVICE

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.

Also known as: glaucoma valve surgery

BGI model 101-350 placement (BGI group)

glaucoma implant procedure (Ahmed) DEVICE

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.

Also known as: glaucoma valve surgery

AGV model FP7 or S2 placement (AGV group)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
• 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.

You may not qualify if:

• patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
• had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
• presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
• uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Elbaklish KH, Saleh SM, Gomaa WA. Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study. Clin Ophthalmol. 2020 Jan 8;14:29-39. doi: 10.2147/OPTH.S224654. eCollection 2020.

  PMID: 32021066 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Neovascular; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants were randomized to BGI model 101-350 placement (BGI group) or an AGV model FP7or S2 placement (AGV group). Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 2, 2020
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 20, 2016
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share