Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy
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|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|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887873
|Department of Ophthalmology, Medical University of Vienna, Austria|
|Vienna, Austria, 1090|