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

Sponsor

Croma-Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01887873

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Cataract	Device: Hyaluronan Thiomer i.o. implant	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Hyaluronan Thiomer i.o. implantable device active treatment	Device: Hyaluronan Thiomer i.o. implant

Arm

Intervention/Treatment

Other: Hyaluronan Thiomer i.o. implantable device

active treatment

Device: Hyaluronan Thiomer i.o. implant

Outcome Measures

Primary Outcome Measures

Safety [Safety will be assessed up to 12 months.]
Safety will be based on the occurrence of adverse events.

Secondary Outcome Measures

Efficacy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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