High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP
NCT ID: NCT02312362
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2012-11-30
2016-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combined sclerotomy ab interno and phaco
Combined sclerotomy ab interno and phacoemulsification with IOL implantation
Combined sclerotomy ab interno and phaco
Phacoemulsification with IOL implantation
Phacoemulsification with IOL implantation
Phacoemulsification with IOL implantation
Interventions
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Combined sclerotomy ab interno and phaco
Phacoemulsification with IOL implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Geneva, Switzerland
OTHER
Oertli Instrumente AG
INDUSTRY
Responsible Party
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Principal Investigators
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Farhad Hafezi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Geneva, Switzerland
Locations
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Aswān, , Egypt
Kiel, , Germany
Mumbai, , India
Geneva, , Switzerland
Reinach, , Switzerland
Countries
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Central Contacts
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References
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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.
Other Identifiers
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HFDS_PS_v9
Identifier Type: -
Identifier Source: org_study_id