Status unknownNCT02312362HFDS_abinternoUpdated Dec 9, 2014

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

An interventional study of Combined sclerotomy ab interno and phaco and Phacoemulsification with IOL implantation in Cataract, Glaucoma and POAG, sponsored by Oertli Instrumente AG. Status unknown at 5 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-09.

Sponsored by Oertli Instrumente AG · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 108
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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

Conditions studied

Cataract
Glaucoma
POAG

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Keywords

HFDS
ab interno
MIGS
surgery

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 108 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

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Lead sponsor

This is the only study on the registry with Oertli Instrumente AG as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 108 participants (estimated)

Study arms

Experimental
Combined sclerotomy ab interno and phaco
Combined sclerotomy ab interno and phacoemulsification with IOL implantation
Procedure: Combined sclerotomy ab interno and phaco
Active comparator
Phacoemulsification with IOL implantation
Phacoemulsification with IOL implantation
Procedure: Phacoemulsification with IOL implantation

Interventions

ProcedureCombined sclerotomy ab interno and phaco
Also known as: High Frequency Deep Sclerotomy (=HFDS), HFDS, STT (formerly), abee tip, Cataract surgery combined with HFDS
ProcedurePhacoemulsification with IOL implantation
Also known as: Phacoemulsification, Phaco, Cataract Surgery

What researchers measure

Primary outcomes

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

Study locations

4 of 5 sites recruiting

Aswan, Egypt
Completed
Kiel, Germany
Recruiting
Mumbai, India
Recruiting
Geneva, Switzerland
Recruiting
Reinach, Switzerland
Recruiting

References and documents

Publications

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. PubMed 20520572 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02312362
Lead sponsor: Oertli Instrumente AG
Collaborators: University of Geneva, Switzerland
Responsible party: Sponsor
First posted: Dec 9, 2014
Start date: Nov 2012
Primary completion: Jun 2015 (estimated)
Completion: Dec 2016 (estimated)
Last update: Dec 9, 2014

Study contacts

Lothar Knuenz

Contact

lothar.knuenz@oertli-instruments.com

Farhad Hafezi, MD, PhD

principal investigator · University of Geneva, Switzerland

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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