NCT03160690

Brief Summary

Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

June 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

May 17, 2017

Last Update Submit

May 18, 2017

Conditions

Choroidal ThicknessOpen Angle GlaucomaNon Penetrating Deep Sclerectomy

Keywords

Choroidal thicknessOpen Angle GlaucomaNon penetrating deep sclerectomy

Outcome Measures

Primary Outcomes (2)

  • Change in Choroidal thickness

    Choroidal thickness measured by optic coherence tomography

    before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy

  • Change in Intraocular pressure

    mmHg

    before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy

Interventions

Non penetrating deep sclerectomyPROCEDURE

Non penetrating deep sclerectomy for open angle glaucoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with progressive open angle glaucoma although topical treatment with indication for non penetrating deep sclerectomy

You may qualify if:

  • Progressive Primary Open Angle Glaucoma

You may not qualify if:

  • Age under 18yrs
  • Myopia or Hyperopia higher than -6D or +6D
  • Secondary glaucoma
  • Ocular surgery other than cataract
  • Other ocular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Sandra Gómez Sánchez, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

  • Pau Romera Romero, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

  • Jorge Loscos Arenas, PhD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Gómez Sánchez, MD

CONTACT

0034934978919gomezsanchez.s@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

June 17, 2017

Primary Completion

November 17, 2017

Study Completion

May 17, 2018

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)