Clinical trial NCT01887873: Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Open Angle Glaucoma
Cataract
Keywords: open angle glaucoma
cataract
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Primary open angle glaucoma with uncontrolled IOP (IOP \> 21 mmHg or more) despite maximally tolerated topical medication
* Clinically significant cataract as judged by the investigator
* Scheduled for combined cataract/glaucoma surgery

Exclusion Criteria:

Any of the following will exclude a subject from the study:

* Participation in a clinical trial in the 3 weeks preceding the study
* Presence or history of a severe medical condition as judged by the clinical investigator
* Wearing of contact lenses
* Loss of mean deviation of visual field testing of 15 dB or more
* Diabetic retinopathy
* Dysgenetic glaucoma, secondary glaucoma or any type of angle closure glaucoma
* Previous argon laser trabeculoplasty
* Severe dry eye syndrome as judged by the investigator
* Ocular infection or clinically significant inflammation as judged by the investigator
* Ocular surgery in the 12 months preceding the study
* History of glaucoma surgery in the study eye
* Neovascular form of age related macular degeneration
* The following lenses will not be implanted during cataract surgery Multifocal lenses Toric lenses PMMA lenses
* Ametropy \>/= 6 Dpt
* Patients in which the surgical procedure cannot be performed or completed according to the protocol for any reason will be excluded and replaced.
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Safety
timeFrame: Safety will be assessed up to 12 months.
Secondary outcomes:
measure: Efficacy
timeFrame: Efficacy assessments will be performed up to 12 months.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology, Medical University of Vienna, Austria
Study officials:
References: