open prospective clinical single center single-armed clinical study for implantation of a telemetric intraocular pressuresensor in humans

Not Applicable

Recruiting

• Conditions: H26.8; H40.1; Primary open-angle glaucoma; Other specified cataract

• Registration Number: DRKS00003335
• Lead Sponsor: ImplanData Ophthalmic Products GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

primary open-angle glaucoma, cataract, intraocualr pressure under control, age 18-80 years, informed consent, understanding of the study purpose and study design, signed informed consent

Exclusion Criteria

sekundary glaucoma, diseases of the cornea, diabetic retinoapthy, uveitis, retinal detechment, intraocular surgery < 6 month, intraocular pressure out of control, axial length <22mm, missing comprehension of the study, severe life-limiting diseases, psychiatric diseases, prgnancy, participance in an other clinical study, other active medical implants

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6 month control: determination of the safety of the implantation of the telemtric intraocular pressure sensor in the human eye.<br>Safety measurements are performed at each visit using ophthalmological non-invasive diagnostics (slitlamp, intraocular pressure, visual fields, cornea examinations, macula structure, visual acuity and refraction.<br>Adverse events will be surveyed.<br>

Secondary Outcome Measures

Name	Time	Method
Evaluation of the precision and reproducibility of the telemtric intraocular pressure measurement with an implanted pressure sensor in humans, comparison of intraocular pressure values with a reference tonometer and evaluation of self-tonometry. (Visit month 1-6 and visit month 7-12)