GlaucomaNCT01906138
An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy
A study testing SENSIMED Triggerfish® in people with Glaucoma, run by Sensimed AG at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- SENSIMED Triggerfish®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis Memorial Research Institute, Glaucoma facility
Haryāna, Haryana, 122002
About this study
Official 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
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.
- Conditions
- Glaucoma
- Being tested
- SENSIMED Triggerfish®
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED Triggerfish®Device
All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish
| Study group | Role | What they receive |
|---|---|---|
| SENSIMED Triggerfish® | Other | All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish Receives: Device: SENSIMED Triggerfish® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
Measured: 24 hours
Secondary outcomes (3)
To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG
Measured: 24 hours
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients
Measured: 24 hours
To assess the comfort of contact lens sensor wear in patients of Indian origin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shibal Bhartiya, MD, Principal investigator, Fortis Memorial Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906138
- Sponsor's protocol ID
- TF-1106
- Status last verified
- Aug 2014
- First submitted
- 19 Jul 2013
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01906138
- Acronym / sponsor ID
- TF-1106
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSIMED Triggerfish® | Other | Device: SENSIMED Triggerfish®All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSIMED Triggerfish®All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish | Device | SENSIMED Triggerfish® |
Primary outcome
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
3 secondary outcomes
To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG
Time frame: 24 hours
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients
Time frame: 24 hours
To assess the comfort of contact lens sensor wear in patients of Indian origin
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shibal Bhartiya, MD principal investigator
Fortis Memorial Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish® in people with Glaucoma, run by Sensimed AG at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.