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

This study has been completed.
Information provided by (Responsible Party):
Sensimed AG Identifier:
First received: January 10, 2013
Last updated: November 16, 2015
Last verified: November 2015

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 Intervention
Primary Open Angle Glaucoma Pigmentary Glaucoma Pseudoexfoliative Glaucoma Device: Sensimed Triggerfish

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

Enrollment: 23
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  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 identifier: NCT01767753

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

Responsible Party: Sensimed AG Identifier: NCT01767753     History of Changes
Other Study ID Numbers: TF-1207
Study First Received: January 10, 2013
Last Updated: November 16, 2015

Keywords provided by Sensimed AG:

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases processed this record on September 21, 2017