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

Sponsor
Oertli Instrumente AG (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02312362
Collaborator
University of Geneva, Switzerland (Other)
108
Enrollment
5
Locations
2
Arms
49
Duration (Months)
21.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Combined sclerotomy ab interno and phaco
  • Procedure: Phacoemulsification with IOL implantation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    Phacoemulsification with IOL implantation

    Procedure: Phacoemulsification with IOL implantation
    Other Names:
  • Phacoemulsification
  • Phaco
  • Cataract Surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [Baseline screening till 3 year post-op]

    2. visual acuity [Baseline screening till 3 year post-op]

    3. decrease in anti glaucoma medications [Baseline screening till 3 year post-op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan Egypt
    2 Kiel Germany
    3 Mumbai India
    4 Geneva Switzerland
    5 Reinach Switzerland

    Sponsors and Collaborators

    • Oertli Instrumente AG
    • University of Geneva, Switzerland

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Oertli Instrumente AG
    ClinicalTrials.gov Identifier:
    NCT02312362
    Other Study ID Numbers:
    • HFDS_PS_v9
    First Posted:
    Dec 9, 2014
    Last Update Posted:
    Dec 9, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Oertli Instrumente AG
    HFDS
    ab interno
    MIGS
    surgery
    Additional relevant MeSH terms:
    Glaucoma
    Cataract

    Study Results

    No Results Posted as of Dec 9, 2014