Open Angle GlaucomaNCT05876936
Prospective, Open Label Study to Assess 24hs IOP Recorded With Triggerfish® in Patients With OAG Before and After DSCI
A study testing contact lens sensor (CLS) SENSIMED Triggerfish® in people with Open Angle Glaucoma, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
A prospective, open label study to assess the 24-hour intraocular pressure pattern recorded with SENSIMED Triggerfish® in patients with open angle glaucoma before and after deep sclerectomy with collagen implant Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- contact lens sensor (CLS) SENSIMED Triggerfish®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Jul 2015
- 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 Open Angle Glaucoma (OAG)
- Documented glaucomatous Visual Field damage with MD more negative than -2 dB
- Progressing glaucomatous damage justifying a deep sclerectomy with collagen implant (DSCI)
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Who cannot join
- • History of ocular surgery within the last 3 months on the study eye
- History of ocular laser treatment on the study eye
- Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
- Severe dry eye syndrome on the study eye
- Patients with allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
Show all 9Show fewer
- 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 SENSIMED Triggerfish® user manual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With Triggerfish® in Patients With Open Angle Glaucoma Before and After DSCI
A prospective, open label study to assess the 24-hour intraocular pressure pattern recorded with SENSIMED Triggerfish® in patients with open angle glaucoma before and after deep sclerectomy with collagen implant
Read the detailed description
This is a prospective, open label study to assess the 24-hour IOP pattern recorded by SENSIMED Triggerfish® in Open Angle Glaucoma (OAG) patients before and after deep sclerectomy with collagen implant (DSCI).
After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. The contact lens sensor (CLS) SENSIMED Triggerfish® will be placed on the study eye as selected for DSCI, for a baseline 24-hour IOP pattern recording session (S1), within 7 days preceding the surgical procedure. Patients will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual lifestyle as possible. A patient diary will be distributed for the capture of patient activities during the IOP pattern recording. Upon completion of S1, the contact lens sensor (CLS) SENSIMED Triggerfish® will be removed and a final ophthalmic examination will be conducted. The patient diary will be collected and concomitant medication will be reported. The surgery will be scheduled within 2 days following S1.
Unless contraindicated (e.g. large filtering bleb precluding placement of the contact lens sensor (CLS) SENSIMED Triggerfish®), patients will undergo a second 24-hour contact lens sensor (CLS) SENSIMED Triggerfish® IOP pattern recording session (S2) on the study eye 3 months after the surgical procedure. S2 will start at the same time of day ± 30 min as S1, preferably at a time that allows for sufficient recording of the wake-to-sleep and the sleep-to-wake phases. Prior to S2 and upon completion of thereof, ophthalmic examinations will be conducted and patient diary will be collected. In addition, any specifics regarding the DSCI and medication will be reported. A visual field (VF) assessment will also be performed to evaluate the changes after deep sclerectomy with collagen implant.
Patients will undergo a third 24-hour SENSIMED Triggerfish® IOP pattern recording session (S3) on the study eye 12 months after the surgical procedure. S3 will start at the same time of day ± 30 min as S2, preferably at a time that allows for sufficient recording of the wake-to-sleep and the sleep-to-wake phases. Prior to S3 and upon completion of thereof, ophthalmic examinations will be conducted and patient diary will be collected. In addition, any specifics regarding the deep sclerectomy with collagen implant (DSCI) and medication will be reported. A visual field assessment will also be performed to evaluate the changes after deep sclerectomy with collagen implant (DSCI).This concludes the study for the patients.
Hence, the overall study duration for the patient is limited to 13 months. The study has been planned to recruit at least 40 eligible patients within 11 months from initiation. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 24 months or less. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.
- Conditions
- Open Angle Glaucoma
- Being tested
- contact lens sensor (CLS) SENSIMED Triggerfish®
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact lens sensor (CLS) SENSIMED Triggerfish®Device
contact lens sensor CLS placing and fitting evaluation, 24h recording
| Study group | Role | What they receive |
|---|---|---|
| contact lens sensor Triggerfish® in patients selected for deep sclerectomy with collagen implant | Other | The contact lens sensor (CLS) SENSIMED Triggerfish® in will be placed on the study eye as selected for deep sclerectomy with collagen implant (DSCI) Receives: Device: contact lens sensor (CLS) SENSIMED Triggerfish® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between the nycthemeral IOP patterns recorded with TF during two 24-hour periods in patients with OAG
Nycthemeral IOP patterns differences will be evaluated with SENSIMED Triggerfish® recording for two 24hs periods in Open Angle Glaucoma patients comparing from baseline to 3 and 12 months
Measured: Baseline, 3 months and 12 months
Secondary outcomes (3)
Changes in diurnal and nocturnal IOP patterns
Evaluation of the effect of deep sclerectomy with collagen implant (DSCI) on diurnal and nocturnal IOP patterns
Measured: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Changes in visual field
Determination of changes in visual field
Measured: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Number of Adverse Events
Evaluation of the safety and tolerability evaluation through the number of adverse effects
Measured: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Principal investigator left the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kaweh Mansouri, University Hospital, Geneva
- Investigators
- Kaweh Mansouri, Dr MD, Principal investigator, Univeresity Hospital Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876936
- Sponsor's protocol ID
- TF-1307
- Status last verified
- May 2023
- First submitted
- 24 Apr 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With Triggerfish® in Patients With Open Angle Glaucoma Before and After DSCI
- ClinicalTrials.gov ID
- NCT05876936
- Acronym / sponsor ID
- TF-1307
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the hospital
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 May 2023 (actual)
- 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.
A prospective, open label study to assess the 24-hour intraocular pressure pattern recorded with SENSIMED Triggerfish® in patients with open angle glaucoma before and after deep sclerectomy with collagen implant
Detailed description
This is a prospective, open label study to assess the 24-hour IOP pattern recorded by SENSIMED Triggerfish® in Open Angle Glaucoma (OAG) patients before and after deep sclerectomy with collagen implant (DSCI).
After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. The contact lens sensor (CLS) SENSIMED Triggerfish® will be placed on the study eye as selected for DSCI, for a baseline 24-hour IOP pattern recording session (S1), within 7 days preceding the surgical procedure. Patients will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual lifestyle as possible. A patient diary will be distributed for the capture of patient activities during the IOP pattern recording. Upon completion of S1, the contact lens sensor (CLS) SENSIMED Triggerfish® will be removed and a final ophthalmic examination will be conducted. The patient diary will be collected and concomitant medication will be reported. The surgery will be scheduled within 2 days following S1.
Unless contraindicated (e.g. large filtering bleb precluding placement of the contact lens sensor (CLS) SENSIMED Triggerfish®), patients will undergo a second 24-hour contact lens sensor (CLS) SENSIMED Triggerfish® IOP pattern recording session (S2) on the study eye 3 months after the surgical procedure. S2 will start at the same time of day ± 30 min as S1, preferably at a time that allows for sufficient recording of the wake-to-sleep and the sleep-to-wake phases. Prior to S2 and upon completion of thereof, ophthalmic examinations will be conducted and patient diary will be collected. In addition, any specifics regarding the DSCI and medication will be reported. A visual field (VF) assessment will also be performed to evaluate the changes after deep sclerectomy with collagen implant.
Patients will undergo a third 24-hour SENSIMED Triggerfish® IOP pattern recording session (S3) on the study eye 12 months after the surgical procedure. S3 will start at the same time of day ± 30 min as S2, preferably at a time that allows for sufficient recording of the wake-to-sleep and the sleep-to-wake phases. Prior to S3 and upon completion of thereof, ophthalmic examinations will be conducted and patient diary will be collected. In addition, any specifics regarding the deep sclerectomy with collagen implant (DSCI) and medication will be reported. A visual field assessment will also be performed to evaluate the changes after deep sclerectomy with collagen implant (DSCI).This concludes the study for the patients.
Hence, the overall study duration for the patient is limited to 13 months. The study has been planned to recruit at least 40 eligible patients within 11 months from initiation. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 24 months or less. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contact lens sensor Triggerfish® in patients selected for deep sclerectomy with collagen implant | Other | Device: contact lens sensor (CLS) SENSIMED Triggerfish®The contact lens sensor (CLS) SENSIMED Triggerfish® in will be placed on the study eye as selected for deep sclerectomy with collagen implant (DSCI) |
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 Open Angle Glaucoma (OAG)
- Documented glaucomatous Visual Field damage with MD more negative than -2 dB
- Progressing glaucomatous damage justifying a deep sclerectomy with collagen implant (DSCI)
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
Key exclusion criteria (9 listed)
- • History of ocular surgery within the last 3 months on the study eye
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 |
|---|---|---|
| contact lens sensor (CLS) SENSIMED Triggerfish®contact lens sensor CLS placing and fitting evaluation, 24h recording | Device | contact lens sensor Triggerfish® in patients selected for deep sclerectomy with collagen implant |
Primary outcome
Changes between the nycthemeral IOP patterns recorded with TF during two 24-hour periods in patients with OAG
Time frame: Baseline, 3 months and 12 months
Nycthemeral IOP patterns differences will be evaluated with SENSIMED Triggerfish® recording for two 24hs periods in Open Angle Glaucoma patients comparing from baseline to 3 and 12 months
3 secondary outcomes
Changes in diurnal and nocturnal IOP patterns
Time frame: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Changes in visual field
Time frame: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Number of Adverse Events
Time frame: 3 months and 12 months after deep sclerectomy with collagen implant (DSCI)
Results and safety
The study was stopped early (reason given: Principal investigator left the hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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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.
Kaweh Mansouri, Dr MD principal investigator
Univeresity Hospital Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contact lens sensor (CLS) SENSIMED Triggerfish® in people with Open Angle Glaucoma, run by University Hospital, Geneva at 1 site in Switzerland.
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 9 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: stopped early, as of the sponsor's last update on 26 May 2023. 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 Switzerland. 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 was stopped early (reason given: Principal investigator left the hospital). Results are not available in the source record.
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?
Changes between the nycthemeral IOP patterns recorded with TF during two 24-hour periods in patients with OAG (time frame: Baseline, 3 months and 12 months). 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 May 2023.