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

Comparative Clinical Trial on the Efficacy and Safety of Non-resorbable Uveoscleral Implant Associated With Absorbable Collagen Matrix vs Isolated Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy in Glaucoma Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04586738

Enrollment

120

Registered

2020-10-14

Start date

2020-09-01

Completion date

2021-12-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREnon-perforating deep sclerectomy surgery

Non-penetrating deep sclerectomy is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma.This surgery is performed to facilitate the outflow of aqueous humour from the anterior chamber to the subconjunctival space through a natural membrane (trabeculo-Descemet's window). This enables a more physiological reduction of intraocular pressure to be achieved.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Evaluations will be done an outcome assessor that do not know the intervention group

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Intraocular pressure	24 hours after surgery, 3 months, 12 months, 24 months	Comparison of intraocular pressure measurements

Secondary

Measure	Time frame	Description
Number of adverse events	24 hours after surgery, 3 months, 12 months, 24 months	Adverse events spontaneous by subject (Safety and tolerability)

Countries

Spain

Contacts

Primary ContactJéssica Botella García, MD

Jessicabotga@gmail.com+34691801518

Backup ContactJordi Loscos, MD

jordiloscos4@hotmail.com+34691801518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026