Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy

Germans Trias i Pujol Hospital

Status: Unknown

Conditions: Glaucoma

Treatments: Procedure: non-perforating deep sclerectomy surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04586738

Implants in deep sclerectomy

Details and patient eligibility

About

The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.

Full description

The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years of age
• Primary or secondary open-angle glaucoma
• High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
• Intolerance to medication.

Exclusion criteria

• Patients with previous glaucoma surgery
• Previous ocular surgery in the last 6 months
• Previous history of Laser trabeculoplasty in the last 12 months
• Moderate or severe diabetic retinopathy
• Active or recurrent eye disease (uveitis)
• Plateau iris
• Ocular neovascularization
• Aphakia
• Neovascular angle-closure glaucoma
• Previous history of intraocular or extraocular malignant neoplasm
• Pregnancy or lactation period, axial length> 26mm and <20mm
• Unwillingness for participating

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Non-resorbable uveoscleral implant associated with absorbable collagen matrix

Other group

Description:

non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix

Treatment:

Procedure: non-perforating deep sclerectomy surgery

Isolated absorbable collagen matrix implant

Other group

Description:

non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant

Treatment:

Procedure: non-perforating deep sclerectomy surgery