Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy
|ClinicalTrials.gov Identifier: NCT01887873|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : April 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma Cataract||Device: Hyaluronan Thiomer i.o. implant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2014|
U.S. FDA Resources
Hyaluronan Thiomer i.o. implantable device
|Device: Hyaluronan Thiomer i.o. implant|
- Safety [ Time Frame: Safety will be assessed up to 12 months. ]Safety will be based on the occurrence of adverse events.
- Efficacy [ Time Frame: Efficacy assessments will be performed up to 12 months. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887873
|Department of Ophthalmology, Medical University of Vienna, Austria|
|Vienna, Austria, 1090|