Prospective, Open Label Study to Assess 24hs IOP Recorded With Triggerfish® in Patients With OAG Before and After DSCI

NCT ID: NCT05876936

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

Brief 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

contact lens sensor Triggerfish® in patients selected for deep sclerectomy with collagen implant

The contact lens sensor (CLS) SENSIMED Triggerfish® in will be placed on the study eye as selected for deep sclerectomy with collagen implant (DSCI)

Group Type: OTHER

contact lens sensor (CLS) SENSIMED Triggerfish®

Intervention Type: DEVICE

contact lens sensor CLS placing and fitting evaluation, 24h recording

Interventions

contact lens sensor (CLS) SENSIMED Triggerfish®

contact lens sensor CLS placing and fitting evaluation, 24h recording

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kaweh Mansouri

Chef de clinique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaweh Mansouri, Dr MD

Role: PRINCIPAL_INVESTIGATOR

Univeresity Hospital Geneva

Locations

University Hospital Geneva

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

TF-1307

Identifier Type: -

Identifier Source: org_study_id