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

Primary Purpose

Cataract, Glaucoma, POAG

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Combined sclerotomy ab interno and phaco
Phacoemulsification with IOL implantation
Sponsored by
Oertli Instrumente AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring HFDS, ab interno, MIGS, surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined sclerotomy ab interno and phaco

Phacoemulsification with IOL implantation

Arm Description

Combined sclerotomy ab interno and phacoemulsification with IOL implantation

Phacoemulsification with IOL implantation

Outcomes

Primary Outcome Measures

Intraocular pressure
visual acuity
decrease in anti glaucoma medications

Secondary Outcome Measures

Full Information

First Posted
December 5, 2014
Last Updated
December 5, 2014
Sponsor
Oertli Instrumente AG
Collaborators
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02312362
Brief Title
High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP
Acronym
HFDS_abinterno
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oertli Instrumente AG
Collaborators
University of Geneva, Switzerland

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Glaucoma, POAG
Keywords
HFDS, ab interno, MIGS, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined sclerotomy ab interno and phaco
Arm Type
Experimental
Arm Description
Combined sclerotomy ab interno and phacoemulsification with IOL implantation
Arm Title
Phacoemulsification with IOL implantation
Arm Type
Active Comparator
Arm Description
Phacoemulsification with IOL implantation
Intervention Type
Procedure
Intervention Name(s)
Combined sclerotomy ab interno and phaco
Other Intervention Name(s)
High Frequency Deep Sclerotomy (=HFDS), HFDS, STT (formerly), abee tip, Cataract surgery combined with HFDS
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification with IOL implantation
Other Intervention Name(s)
Phacoemulsification, Phaco, Cataract Surgery
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Baseline screening till 3 year post-op
Title
visual acuity
Time Frame
Baseline screening till 3 year post-op
Title
decrease in anti glaucoma medications
Time Frame
Baseline screening till 3 year post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lothar Knuenz
Email
lothar.knuenz@oertli-instruments.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Hafezi, MD, PhD
Organizational Affiliation
University of Geneva, Switzerland
Official's Role
Principal Investigator
Facility Information:
City
Aswan
Country
Egypt
Individual Site Status
Completed
City
Kiel
Country
Germany
Individual Site Status
Recruiting
City
Mumbai
Country
India
Individual Site Status
Recruiting
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
City
Reinach
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
20520572
Citation
Pajic B, Pajic-Eggspuehler B, Haefliger I. New minimally invasive, deep sclerotomy ab interno surgical procedure for glaucoma, six years of follow-up. J Glaucoma. 2011 Feb;20(2):109-14. doi: 10.1097/IJG.0b013e3181dddf31.
Results Reference
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High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP

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