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Status unknownNCT04586738Updated Feb 18, 2021

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

An interventional study of non-perforating deep sclerectomy surgery in Glaucoma, sponsored by Germans Trias i Pujol Hospital. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Germans Trias i Pujol Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 120 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • Other
    Isolated absorbable collagen matrix implant

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

    Procedure: non-perforating deep sclerectomy surgery

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.

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What researchers measure

Primary outcomes

  1. Number of Intraocular pressure

    Comparison of intraocular pressure measurements

    Time frame: 24 hours after surgery, 3 months, 12 months, 24 months

Secondary outcomes

  1. Number of adverse events

    Adverse events spontaneous by subject (Safety and tolerability)

    Time frame: 24 hours after surgery, 3 months, 12 months, 24 months

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Study locations

2 of 2 sites recruiting
  • Jéssica Botella García
    Barcelona, 08391, Spain
    Recruiting
  • Hospital Universitario Germans Trias i Pujol
    Barcelona, Spain
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04586738
Lead sponsor
Germans Trias i Pujol Hospital
Responsible party
Sponsor
First posted
Oct 14, 2020
Start date
Sep 1, 2020
Primary completion
Nov 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 18, 2021

Study contacts

Jéssica Botella García, MD
Contact
Jessicabotga@gmail.com
+34691801518
Jordi Loscos, MD
Contact
jordiloscos4@hotmail.com
+34691801518
Jéssica Botella García, MD
principal investigator · Germans Trias i Pujol Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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