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

NCT05876936 | Terminated

• 1 other identifier: TF-1307
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 3 months and 12 months

Secondary Outcomes (3)

• Changes in diurnal and nocturnal IOP patterns

  3 months and 12 months after deep sclerectomy with collagen implant (DSCI)

• Changes in visual field

  3 months and 12 months after deep sclerectomy with collagen implant (DSCI)

• Number of Adverse Events

  3 months and 12 months after deep sclerectomy with collagen implant (DSCI)

Study Arms (1)

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)

Device: contact lens sensor (CLS) SENSIMED Triggerfish®

Interventions

contact lens sensor (CLS) SENSIMED Triggerfish® DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Kaweh Mansouri, Dr MD

  Univeresity Hospital Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de clinique

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 26, 2023
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

CH (1)