High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP (HFDS_abinterno)

December 5, 2014 updated by: Oertli Instrumente AG

HFDS ab Interno - to Compare Intraocular Pressure (IOP) Lowering Effect of Combined High Frequency Deep Sclerotomy ab Interno (HFDS ab Interno) With Phacoemulsification and Phacoemulsification Alone, in Primary Open Angle Glaucoma Patients

Objective:

To compare intraocular pressure lowering effect of combined sclerotomy ab interno with phacoemulsification and phacoemulsification alone, in primary or secondary open angle glaucoma patients.

Study design:

Prospective, randomized, case- control interventional surgical trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Aswan, Egypt
        • Completed
  • Germany
      • Kiel, Germany
        • Recruiting
  • India
      • Mumbai, India
        • Recruiting
  • Switzerland
      • Geneva, Switzerland
        • Recruiting
      • Reinach, Switzerland
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.

Exclusion Criteria:

  • One eyed patients
  • Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
  • The presence of extreme narrow angle with complete or partial closure in either eye, except for occludable angles treated with a patent iridectomy
  • Any abnormality preventing reliable applanation tonometry, any opacity or patient uncooperativeness that would restrict adequate examination of the ocular fundus or anterior chamber of either eye
  • The risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's opinion
  • Any clinically significant, serious, or severe medical or psychiatric condition; any condition that, in the investigator's opinion, would interfere with optimal participation in the study or present a special risk to the patient
  • Participation in any other investigational study within 30 days prior to baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined sclerotomy ab interno and phaco
Combined sclerotomy ab interno and phacoemulsification with IOL implantation
Procedure: Combined sclerotomy ab interno and phaco
Other Names:
  • High Frequency Deep Sclerotomy (=HFDS)
  • HFDS
  • STT (formerly)
  • abee tip
  • Cataract surgery combined with HFDS
Active Comparator: Phacoemulsification with IOL implantation
Procedure: Phacoemulsification with IOL implantation
Other Names:
  • Phacoemulsification
  • Phaco
  • Cataract Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: Baseline screening till 3 year post-op
Baseline screening till 3 year post-op
visual acuity
Time Frame: Baseline screening till 3 year post-op
Baseline screening till 3 year post-op
decrease in anti glaucoma medications
Time Frame: Baseline screening till 3 year post-op
Baseline screening till 3 year post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oertli Instrumente AG

Collaborators

University of Geneva, Switzerland

Investigators

  • Principal Investigator: Farhad Hafezi, MD, PhD, University of Geneva, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFDS_PS_v9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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