Status:
UNKNOWN
High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP
Lead Sponsor:
Oertli Instrumente AG
Collaborating Sponsors:
University of Geneva, Switzerland
Conditions:
Cataract
Glaucoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 patien...
Eligibility Criteria
Inclusion
- Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02312362
Start Date
November 1 2012
End Date
December 1 2016
Last Update
December 9 2014
Active Locations (5)
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1
Aswān, Egypt
2
Kiel, Germany
3
Mumbai, India
4
Geneva, Switzerland