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

• Sponsor: Germans Trias i Pujol Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04586738
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site: 60
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: non-perforating deep sclerectomy surgery	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Evaluations will be done an outcome assessor that do not know the intervention group
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Non-resorbable uveoscleral implant associated with absorbable collagen matrix non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix	Procedure: non-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.
Other: Isolated absorbable collagen matrix implant non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant	Procedure: non-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.

Outcome Measures

Primary Outcome Measures

1. Number of Intraocular pressure [24 hours after surgery, 3 months, 12 months, 24 months]

   Comparison of intraocular pressure measurements

Secondary Outcome Measures

1. Number of adverse events [24 hours after surgery, 3 months, 12 months, 24 months]

   Adverse events spontaneous by subject (Safety and tolerability)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jéssica Botella García	Barcelona		Spain	08391
2	Hospital Universitario Germans Trias i Pujol	Barcelona		Spain

Sponsors and Collaborators

• Germans Trias i Pujol Hospital

Investigators

• Principal Investigator: Jéssica Botella García, MD, Germans Trias i Pujol Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Germans Trias i Pujol Hospital
• ClinicalTrials.gov Identifier: NCT04586738
• Other Study ID Numbers: Implants in deep sclerectomy
• First Posted: Oct 14, 2020
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Feb 18, 2021