Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy

Launched by CROMA-PHARMA GMBH · Jun 25, 2013

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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