Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2025-12-17 @ 3:00 AM
Study NCT ID:
NCT05876936
Status:
None
Last Update Posted:
2023-05-26 00:00:00
First Post:
2015-04-24 00:00:00
Brief Title:
Prospective, Open Label Study to Assess 24hs IOP Recorded With Triggerfish® in Patients With OAG Before and After DSCI
Sponsor:
University Hospital Geneva
Organization:
University Hospital, Geneva
Study Overview
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
Status:
None
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal investigator left the hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 hisher 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 eg 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 DSCIThis 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
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 hisher 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 eg 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 DSCIThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None