Clinical trial NCT02312362: High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Glaucoma
POAG
Keywords: HFDS
ab interno
MIGS
surgery
Lead sponsor: Oertli Instrumente AG
Sponsor class: INDUSTRY
Collaborators: name: University of Geneva, Switzerland
First posted: 2014-12-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Intraocular pressure
timeFrame: Baseline screening till 3 year post-op
measure: visual acuity
timeFrame: Baseline screening till 3 year post-op
measure: decrease in anti glaucoma medications
timeFrame: Baseline screening till 3 year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
city: Kiel
country: Germany
city: Mumbai
country: India
city: Geneva
country: Switzerland
city: Reinach
country: Switzerland
Study officials:
affiliation: University of Geneva, Switzerland
name: Farhad Hafezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.