Primary Open Angle GlaucomaHFDSNCT05466526
Microinvasive Glaucoma Surgery -The Lowering Effect of Intraocular Pressure on Glaucoma Patients With High Frequency Deep Sclerotomy
A study testing High frequency deep sclerotomy (HFDS) in people with Primary Open Angle Glaucoma and Intraocular Pressure, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the efficacy and safety of the procedure. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Intraocular Pressure, Glaucoma Surgery
- What is being tested?
- High frequency deep sclerotomy (HFDS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 30 Jun 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic open angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.
Who cannot join
- Patients with close-angle, congenital, traumatic, neovascular, and uveitic glaucoma, patients with prior penetrating and nonpenetrating glaucoma surgeries or laser therapy, and eyes with corneal opacity precluding visualization of the angle.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
Ko Mei-Lan, MD, +886-7265-4211, aaddch@gmail.com
Wang Wei-Xiang, Student, +886-6533-5416, wales0315@gmail.com
About this study
Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the efficacy and safety of the procedure.
Read the detailed description
[Materials and Methods ] This is a single-centre, prospective, non-blinded, interventional trials designed to evaluate the therapeutic effect and safety of HFDS in POAG patients. A total of 30 subjects were recruited, all of whom were outpatients of the ophthalmology department of attending physician MeiLan Ko in the National Taiwan University Hospital Hsin-Chu Branch. The 20 subjects were all diagnosed with POAG. The surgery was performed in the surgery room of the National Taiwan University Hospital Hsin-Chu Branch. The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedure, nasal six pockets penetrating 1mm deep into the trabecular meshwork and Schlemm's canal were formed to promote aqueous humor outflow.
[Postoperative follow-up and evaluation] The postoperative IOP and visual acuity (VA) were measured in every follow-up visit for 6 months. Postoperatively, Cravit/Lotemax drops were given to prevent inflammation and infections; besides, Pilocarpine 2% eye drops were provided to reduce IOP for postoperative medication.
[Data Statistics and Analysis] Statistical analysis was done by IBMSPSS v21.0 statistical software (IBM Corporation, New York, USA). Data analysis was done by chi square (χ2) test, paired samples T-test and repeated ANOVA measurements with Bonferroni post hoc analysis. The results are considered statistically significant with a P value <0.05.
- Being tested
- High frequency deep sclerotomy (HFDS)
- Keywords
- Primary Open Angle Glaucoma, High frequency deep sclerotomy, Abee glaucoma tip of Oertli
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency deep sclerotomy (HFDS)Procedure or surgery
The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedures, nasal six pockets penetrating 1mm deep from the trabecular meshwork to Schlemm's canal will be formed to promote the aqueous humor outflow.
| Study group | Role | What they receive |
|---|---|---|
| The participants who received HFDS | Experimental | All participants in the arm were suffering from primary open-angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment. Receives: Procedure: High frequency deep sclerotomy (HFDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of intraocular pressure (IOP) after HFDS treatments compared to preoperative IOP.
The postoperative IOP will be measured in every follow-up visit for 6 months after the operation. If the IOP of the participants is lower than that before the operation, and there is no tendency to increase within six months as well as no additional complications occur, the benefits of the primary outcome will be achieved.
Measured: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
Secondary outcomes (1)
Change of visual acuity (VA) after HFDS treatments compared to preoperative VA.
The postoperative visual acuity(VA) will be measured in every follow-up visit for 6 months after the operation. If the VA of the participants is getting better than that before the operation, and there is no tendency to worse within six months as well as no additional complications occur, the benefits of the secondary outcome will be achieved.
Measured: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants in the arm were suffering from chronic open-angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Collaborators
- Local clinic
- Responsible party
- Sponsor
- Investigators
- Li Min-Zhen, investigator, Principal investigator, IRB of NTUH Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466526
- Sponsor's protocol ID
- 111-042-F
- Acronym
- HFDS
- Status last verified
- Dec 2022
- First submitted
- 17 Jul 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical Study Report (CSR) can be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microinvasive Glaucoma Surgery -The Lowering Effect of Intraocular Pressure on Glaucoma Patients With High Frequency Deep Sclerotomy
- ClinicalTrials.gov ID
- NCT05466526
- Acronym / sponsor ID
- HFDS / 111-042-F
- Keywords
- Primary Open Angle Glaucoma, High frequency deep sclerotomy, Abee glaucoma tip of Oertli
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Collaborators
- Local clinic
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- 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.
Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the efficacy and safety of the procedure.
Detailed description
[Materials and Methods ] This is a single-centre, prospective, non-blinded, interventional trials designed to evaluate the therapeutic effect and safety of HFDS in POAG patients. A total of 30 subjects were recruited, all of whom were outpatients of the ophthalmology department of attending physician MeiLan Ko in the National Taiwan University Hospital Hsin-Chu Branch. The 20 subjects were all diagnosed with POAG. The surgery was performed in the surgery room of the National Taiwan University Hospital Hsin-Chu Branch. The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedure, nasal six pockets penetrating 1mm deep into the trabecular meshwork and Schlemm's canal were formed to promote aqueous humor outflow.
[Postoperative follow-up and evaluation] The postoperative IOP and visual acuity (VA) were measured in every follow-up visit for 6 months. Postoperatively, Cravit/Lotemax drops were given to prevent inflammation and infections; besides, Pilocarpine 2% eye drops were provided to reduce IOP for postoperative medication.
[Data Statistics and Analysis] Statistical analysis was done by IBMSPSS v21.0 statistical software (IBM Corporation, New York, USA). Data analysis was done by chi square (χ2) test, paired samples T-test and repeated ANOVA measurements with Bonferroni post hoc analysis. The results are considered statistically significant with a P value <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants in the arm were suffering from chronic open-angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.
| Arm | Type | Receives |
|---|---|---|
| The participants who received HFDS | Experimental | Procedure: High frequency deep sclerotomy (HFDS)All participants in the arm were suffering from primary open-angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic open angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.
Key exclusion criteria (1 listed)
- Patients with close-angle, congenital, traumatic, neovascular, and uveitic glaucoma, patients with prior penetrating and nonpenetrating glaucoma surgeries or laser therapy, and eyes with corneal opacity precluding visualization of the angle.
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 |
|---|---|---|
| High frequency deep sclerotomy (HFDS)The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedures, nasal six pockets penetrating 1mm deep from the trabecular meshwork to Schlemm's canal will be formed to promote the aqueous humor outflow. | Procedure or surgery | The participants who received HFDS |
Primary outcome
Change of intraocular pressure (IOP) after HFDS treatments compared to preoperative IOP.
Time frame: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
The postoperative IOP will be measured in every follow-up visit for 6 months after the operation. If the IOP of the participants is lower than that before the operation, and there is no tendency to increase within six months as well as no additional complications occur, the benefits of the primary outcome will be achieved.
1 secondary outcome
Change of visual acuity (VA) after HFDS treatments compared to preoperative VA.
Time frame: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes. Clinical Study Report (CSR) can be shared
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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.
Li Min-Zhen, investigator principal investigator
IRB of NTUH Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency deep sclerotomy (HFDS) in people with Primary Open Angle Glaucoma and Intraocular Pressure, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 1 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Ko Mei-Lan, doctor (+886-7265-4211, aaddch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of intraocular pressure (IOP) after HFDS treatments compared to preoperative IOP. (time frame: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.