Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy
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.
Open Angle Glaucoma
Device: Hyaluronan Thiomer i.o. implant
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety [ Time Frame: Safety will be assessed up to 12 months. ] [ Designated as safety issue: Yes ]Safety will be based on the occurrence of adverse events.
- Efficacy [ Time Frame: Efficacy assessments will be performed up to 12 months. ] [ Designated as safety issue: No ]Efficacy will be assessed based on postoperative IOP reduction, assessment of the proportion of subjects needing additional IOP lowering medication and the proportion of subjects needing postoperative Neodymium:YAG goniopuncture.
|Study Start Date:||July 2012|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Hyaluronan Thiomer i.o. implantable device
|Device: Hyaluronan Thiomer i.o. implant|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887873
|Department of Ophthalmology, Medical University of Vienna, Austria|
|Vienna, Austria, 1090|