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

This study is currently recruiting participants.
Verified June 2013 by Croma-Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Croma-Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01887873
First received: June 11, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Open Angle Glaucoma
Cataract
Device: Hyaluronan Thiomer i.o. implant
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Croma-Pharma GmbH:

Primary Outcome Measures:
  • Safety [ Time Frame: Safety will be assessed up to 12 months. ] [ Designated as safety issue: Yes ]
    Safety will be based on the occurrence of adverse events.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Efficacy assessments will be performed up to 12 months. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 16
Study Start Date: July 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hyaluronan Thiomer i.o. implantable device
active treatment
Device: Hyaluronan Thiomer i.o. implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887873

Contacts
Contact: Clemens Vass, Prof. Dr. 0043140400 ext 4520 clemens.vass@meduniwien.ac.at
Contact: Hemma Resch, MD 0043140400 ext 7940 hemma.resch@meduniwien.ac.at

Locations
Austria
Department of Ophthalmology, Medical University of Vienna, Austria Recruiting
Vienna, Austria, 1090
Contact: Clemens Vass, Prof. MD    0043140400 ext 4520    clemens.vass@meduniwien.ac.at   
Contact: Hemma Resch, MD    0043140400 ext 7940    hemma.resch@meduniwien.ac.at   
Sponsors and Collaborators
Croma-Pharma GmbH
  More Information

No publications provided

Responsible Party: Croma-Pharma GmbH
ClinicalTrials.gov Identifier: NCT01887873     History of Changes
Other Study ID Numbers: OPHT150611
Study First Received: June 11, 2013
Last Updated: June 25, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Croma-Pharma GmbH:
open angle glaucoma
cataract

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014