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

NCT01887873 | Completed Phase 1

• 1 other identifier: OPHT150611
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Cataract

Keywords

open angle glaucoma; cataract

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety will be based on the occurrence of adverse events.

  Safety will be assessed up to 12 months.

Secondary Outcomes (1)

• Efficacy

  Efficacy assessments will be performed up to 12 months.

Study Arms (1)

Hyaluronan Thiomer i.o. implantable device

OTHER

active treatment

Device: Hyaluronan Thiomer i.o. implant

Interventions

Hyaluronan Thiomer i.o. implant DEVICE

Hyaluronan Thiomer i.o. implantable device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 27, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Last Updated: April 1, 2016

Record last verified: 2013-06

Locations

AU (1)