Status:
COMPLETED
Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy
Lead Sponsor:
Croma-Pharma GmbH
Conditions:
Open Angle Glaucoma
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01887873
Start Date
July 1 2012
Last Update
April 1 2016
Active Locations (1)
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1
Department of Ophthalmology, Medical University of Vienna, Austria
Vienna, Austria, 1090