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OpenTrials
Completed

NCT Number: NCT01906138

An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fortis Memorial Research Institute, Glaucoma facility

Haryāna, Haryana, 122002, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary angle closure (PAC) or primary angle closure glaucoma (PACG) with indication for laser peripheral iridotomy (PAC is defined by the presence of a partial or complete iridotrabecular contact in more than 2 quadrants with either raised intraocular pressure [i.e. more than 21 mmHg] and/or primary adhesion to the trabecular meshwork (peripheral anterior synechiae [PAS]; however, with normal optic disc and visual field. PACG is defined by the presence of iridotrabecular contact with either raised intraocular pressure and/or PAS, and evidence of glaucomatous optic disc and visual field)
  • No intraocular pressure-lowering drug treatment or a 4-week wash-out period prior to study day 0 and throughout the study
  • Aged ≥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 procedure

Exclusion criteria

  • History of acute angle closure glaucoma
  • Secondary angle closure glaucoma
  • History of ocular surgery within the last 3 months
  • History of ocular laser treatment, including previous laser peripheral iridotomy
  • 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

Treatment and study plan

SENSIMED Triggerfish®

Device

All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish

Primary outcomes

  1. The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma

    Time frame: 24 hours

Secondary outcomes

  1. To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG

    Time frame: 24 hours

  2. To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients

    Time frame: 24 hours

  3. To assess the comfort of contact lens sensor wear in patients of Indian origin

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2013
Registry last updated
Aug 26, 2014

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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