Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy

• Sponsor: Germans Trias i Pujol Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03160690
• Collaborator: Pau Romera Romero (Other), Jorge Loscos Arenas (Other), Nevena Romanic Bubalo (Other), Jordi Castellví Manent (Other)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Choroidal Thickness; Open Angle Glaucoma; Non Penetrating Deep Sclerectomy	Procedure: Non penetrating deep sclerectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy
• Anticipated Study Start Date: Jun 17, 2017
• Anticipated Primary Completion Date: Nov 17, 2017
• Anticipated Study Completion Date: May 17, 2018

Outcome Measures

Primary Outcome Measures

1. Change in Choroidal thickness [before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy]

   Choroidal thickness measured by optic coherence tomography

2. Change in Intraocular pressure [before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy]

   mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Progressive Primary Open Angle Glaucoma

Exclusion Criteria:

• Age under 18yrs

• Myopia or Hyperopia higher than -6D or +6D

• Secondary glaucoma

• Ocular surgery other than cataract

• Other ocular pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Germans Trias i Pujol Hospital	Badalona	Barcelona	Spain	08916

Sponsors and Collaborators

• Germans Trias i Pujol Hospital
• Pau Romera Romero
• Jorge Loscos Arenas
• Nevena Romanic Bubalo
• Jordi Castellví Manent

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandra Gómez Sánchez, Principal Investigator, Germans Trias i Pujol Hospital
• ClinicalTrials.gov Identifier: NCT03160690
• Other Study ID Numbers: OFT-ENP-2017-03
• First Posted: May 19, 2017
• Last Update Posted: May 19, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sandra Gómez Sánchez, Principal Investigator, Germans Trias i Pujol Hospital: Choroidal thickness; Open Angle Glaucoma; Non penetrating deep sclerectomy
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of May 19, 2017