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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01767753
First received: January 10, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Adverse events and serious adverse events will be collected throughout the duration of the study


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01767753     History of Changes
Other Study ID Numbers: TF-1207
Study First Received: January 10, 2013
Last Updated: May 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Sensimed AG:
Glaucoma
SLT

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

ClinicalTrials.gov processed this record on July 28, 2014