NCT01887873

Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy

An Open Two-center Study Evaluating the Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy in Patients With Open Angle Glaucoma and Cataract

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating deep sclerectomy procedure. In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open angle glaucoma and clinically significant cataract. Given that a considerable number of glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also of importance because a combined procedure avoids the need of a second operation in this group of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I study). Safety will be assessed based on the occurrence of adverse events. Efficacy assessments will be performed at every visit and efficacy analysis will include: * Proportion of subjects at each study time point which will need additional IOP lowering drug therapy to achieve an IOP reduction to values \< 21 mmHg. If a subject needs more than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP reduction will be recorded. * Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to achieve an IOP reduction to values \< 21 mmHg.

Conditions

• Open Angle Glaucoma
• Cataract

Interventions

Type	Name	Description
DEVICE	Hyaluronan Thiomer i.o. implant

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-04-01
• First posted: 2013-06-27
• Last updated: 2016-04-01

Locations

1 site across 1 country: Austria