IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01906151
First received: July 19, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients


Condition Intervention
Glaucoma
Device: SENSIMED Triggerfish®

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SENSIMED Triggerfish®
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
Device: SENSIMED Triggerfish®
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
  • No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
  • Aged ≥18 years, of either sex
  • Not more than 6 diopters spherical equivalent on the study eye
  • Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

  • History of acute angle closure glaucoma on the study eye
  • Secondary angle closure glaucoma on the study eye
  • History of ocular surgery within the last 3 months on the study eye
  • History of ocular laser treatment, including previous LPI on the study eye
  • Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
  • Severe dry eye syndrome on the study eye
  • Patients with allergy to corneal anesthetic
  • Patients with contraindications for silicone contact lens wear
  • Patients not able to understand the character and individual consequences of the investigation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906151

Locations
France
CHNO des Quinze-Vingts, 28 rue Charenton
Paris, France, 75571
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Christophe Baudouin, MD CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01906151     History of Changes
Other Study ID Numbers: TF-1306
Study First Received: July 19, 2013
Last Updated: May 12, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 20, 2014