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

C

Croma-Pharma

Status and phase

Completed
Phase 1

Conditions

Cataract
Open Angle Glaucoma

Treatments

Device: Hyaluronan Thiomer i.o. implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01887873
OPHT150611

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Hyaluronan Thiomer i.o. implantable device
Other group
Description:
active treatment
Treatment:
Device: Hyaluronan Thiomer i.o. implant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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