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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02312362

Acronym

HFDS_abinterno

Enrollment

108

Registered

2014-12-09

Start date

2012-11-30

Completion date

2016-12-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma, POAG

Keywords

HFDS, ab interno, MIGS, surgery

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

Interventions

PROCEDURECombined sclerotomy ab interno and phaco

PROCEDUREPhacoemulsification with IOL implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Intraocular pressure	Baseline screening till 3 year post-op
visual acuity	Baseline screening till 3 year post-op
decrease in anti glaucoma medications	Baseline screening till 3 year post-op

Countries

Egypt, Germany, India, Switzerland

Contacts

Primary ContactLothar Knuenz

lothar.knuenz@oertli-instruments.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026