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OpenTrials
Completed

NCT Number: NCT01767753

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish

Device

Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2013
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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