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

This study is currently recruiting participants. (see Contacts and Locations)
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: July 29, 2014
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: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 29, 2014
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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 27, 2014