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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Open Angle Glaucoma
• Intervention / Treatment: Device: Hyaluronan Thiomer i.o. implant

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Ophthalmology, Medical University of Vienna, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Hyaluronan Thiomer i.o. implantable device; active treatment	Device: Hyaluronan Thiomer i.o. implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety will be based on the occurrence of adverse events.	Safety will be assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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.	Efficacy assessments will be performed up to 12 months.

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (ESTIMATE): June 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: cataract; open angle glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: OPHT150611