CataractHFDS_abinternoNCT02312362
High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP
A study testing Combined sclerotomy ab interno and phaco and Phacoemulsification with IOL implantation in people with Cataract and Glaucoma, run by Oertli Instrumente AG at 5 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Combined sclerotomy ab interno and phaco and Phacoemulsification with IOL implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
Lothar Knuenz contact
5 sites in 4 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Study site
Geneva
- Recruiting
Study site
Reinach
About this study
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
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
- Being tested
- Combined sclerotomy ab interno and phaco, Phacoemulsification with IOL implantation
- Keywords
- HFDS, ab interno, MIGS, surgery
- Medical subject headings
- Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined sclerotomy ab interno and phacoProcedure or surgery
Also called High Frequency Deep Sclerotomy (=HFDS), HFDS, STT (formerly), abee tip
Phacoemulsification with IOL implantationProcedure or surgery
Also called Phacoemulsification, Phaco, Cataract Surgery
| Study group | Role | What they receive |
|---|---|---|
| Combined sclerotomy ab interno and phaco | Experimental | Combined sclerotomy ab interno and phacoemulsification with IOL implantation Receives: Procedure: Combined sclerotomy ab interno and phaco |
| Phacoemulsification with IOL implantation | Active comparator | Phacoemulsification with IOL implantation Receives: Procedure: Phacoemulsification with IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: Baseline screening till 3 year post-op
visual acuity
Measured: Baseline screening till 3 year post-op
decrease in anti glaucoma medications
Measured: Baseline screening till 3 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oertli Instrumente AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Farhad Hafezi, MD, PhD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312362
- Sponsor's protocol ID
- HFDS_PS_v9
- Acronym
- HFDS_abinterno
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02312362
- Acronym / sponsor ID
- HFDS_abinterno / HFDS_PS_v9
- Keywords
- HFDS, ab interno, MIGS, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Oertli Instrumente AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Geneva, Switzerland
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined sclerotomy ab interno and phaco | Experimental | Procedure: Combined sclerotomy ab interno and phacoCombined sclerotomy ab interno and phacoemulsification with IOL implantation |
| Phacoemulsification with IOL implantation | Active comparator | Procedure: Phacoemulsification with IOL implantationPhacoemulsification with IOL implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined sclerotomy ab interno and phacoAlso: High Frequency Deep Sclerotomy (=HFDS), HFDS, STT (formerly), abee tip | Procedure or surgery | Combined sclerotomy ab interno and phaco |
| Phacoemulsification with IOL implantationAlso: Phacoemulsification, Phaco, Cataract Surgery | Procedure or surgery | Phacoemulsification with IOL implantation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Background: PubMed 20520572Pajic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lothar Knuenz contact
Farhad Hafezi, MD, PhD principal investigator
University of Geneva, Switzerland
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined sclerotomy ab interno and phaco and Phacoemulsification with IOL implantation in people with Cataract and Glaucoma, run by Oertli Instrumente AG at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, Egypt, Germany, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lothar Knuenz (lothar.knuenz@oertli-instruments.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: Baseline screening till 3 year post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014; AzTrials last refreshed its copy on 3 Nov 2026.