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IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01767753
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

Brief Summary:

Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.

The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.


Condition or disease Intervention/treatment
Primary Open Angle Glaucoma Pigmentary Glaucoma Pseudoexfoliative Glaucoma Device: Sensimed Triggerfish

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
Study Start Date : November 2012
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Triggerfish
Device: Sensimed Triggerfish
Device: Sensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours



Primary Outcome Measures :
  1. To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT. [ Time Frame: 1 months ]
    • Wake-to-Sleep slopes
    • Overall variability
    • Diurnal and nocturnal IOP patterns
    • Number of peaks


Secondary Outcome Measures :
  1. To assess IOP patterns of POAG patients during office hours [ Time Frame: 1 month ]

    Overall variability

    • Diurnal and nocturnal IOP patterns
    • Number of peaks in the study population before and after SLT

  2. Safety and tolerability in this patient population [ Time Frame: 1 month ]
    Adverse events and serious adverse events will be collected throughout the duration of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
  • Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB
  • No or stable anti-glaucomatous drug therapy since at least 3 months
  • Structural and/or functional glaucomatous damage
  • Aged more than 18 years, of either sex
  • Not more than 6 diopters spherical equivalent on the study eye
  • Not more than 2 diopters cylinder equivalent on the study eye
  • Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

  • Refractory glaucoma
  • Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
  • Corneal or conjunctival abnormality precluding contact lens adaptation
  • Severe dry eye syndrome
  • 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
  • Participation in other clinical research within the last 4 weeks
  • Any other contra-indication listed in the Triggerfish user manual

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767753


Locations
France
Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts
Paris, France, 75012
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Jean-Philippe Nordmann, MD Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01767753     History of Changes
Other Study ID Numbers: TF-1207
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Sensimed AG:
Glaucoma
SLT

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