Cataract Clinical Trial
— HFDS_abinternoOfficial 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
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
Status | Recruiting |
Enrollment | 108 |
Est. completion date | December 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Oertli Instrumente AG | University of Geneva, Switzerland |
Egypt, Germany, India, Switzerland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure | Baseline screening till 3 year post-op | Yes | |
Primary | visual acuity | Baseline screening till 3 year post-op | No | |
Primary | decrease in anti glaucoma medications | Baseline screening till 3 year post-op | No |
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