Glaucoma, Open-AngleNCT05043831
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial
A study testing DSLT in people with Glaucoma, Open-Angle and Ocular Hypertension, run by BelkinVision.
Trial summary
The objective of this study is to evaluate the effectiveness (Intra-Ocular Pressure lowering) and safety of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese subjects with Primary Open Angle Glaucoma or Ocular Hypertension. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- DSLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 15 Apr 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older, any gender, of Chinese Han ethnicity, with corrected visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension.
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants.
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
- Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule.
- Participant capable of giving informed consent
Who cannot join
- Contraindications to conventional laser trabeculoplasty (e.g., corneal abnormalities, etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
Show all 26Show fewer
- Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
- A visual field MD of worse than -12dB
- Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot.
- At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
- A visual field MD of worse than -12dB in the fellow eye
- Cup:Disc Ratio of more than 0.8
- More than three hypotensive medications required (combination drops are considered as 2 medications)
- Prior incisional or laser glaucoma surgery (including previous SLT or LPI) in the study eye.
- Prior corneal refractive surgery
- Complicated cataract surgery ≤ 6 months prior to enrollment
- Presence of visually significant cataract in the opinion of the investigator
- Clinically significant disease in either eye as determined by the Investigator.
- Clinically significant amblyopia in either eye
- Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- Women who are pregnant or may become pregnant during the course of the study.
- In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP
- Concurrent treatment with topical, nasal, inhaled or systemic steroids.
- Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator.
- Participation in another clinical study, not including a GLAUrious sub-study
About this study
Official title: Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension in Ethnic Chinese Population The Zhuiguang Trial
The objective of this study is to evaluate the effectiveness (Intra-Ocular Pressure lowering) and safety of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese subjects with Primary Open Angle Glaucoma or Ocular Hypertension.
Read the detailed description
Glaucoma, which is very common disease in China, can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is.
The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT in ethnic Chinese population and determine that it is as effective in reducing intraocular pressure.
DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list.
Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- DSLT
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSLTDevice
Also called SLT
Direct-SLT is applied via the limbus to the trabecular meshwork
| Study group | Role | What they receive |
|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT) | Experimental | Subjects will be treated with DSLT Receives: Device: DSLT |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Subjects will be treated with SLT Receives: Device: DSLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction from baseline to 6 months
The primary effectiveness endpoint is the difference between the two treatment groups' change-from-baseline IOP, where change-from-baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at 6 months for each subject.
Measured: 6 months
Secondary outcomes (5)
Mean percentage IOP reduction
Mean percentage reduction in IOP at 3, 6 and 12 months.
Measured: 3, 6, 12 months
Subjects with at least 20% IOP reduction
Proportion of subjects with at least 20% reduction in IOP from baseline
Measured: 6 months
Change in medications
Number of glaucoma medications at 12 months as compared to screening/visit 1 (before treatment) and compared between groups.
Measured: 12 months
Treatment failures
Proportion of subjects in each group who are treatment failures (either had an incisional glaucoma surgery during the 6 months follow-up period, or are treated at the 6 months visit with hypotensive drugs in an equal or higher number than in the screening visit).
Measured: r months
Adverse events
Proportion of ocular adverse events between the 2 arms at 6 and 12 months
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Oct 2021 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Why it stopped: Study didnt start and will be re-designed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BelkinVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Xinghuai, Prof., Principal investigator, Fundan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043831
- Sponsor's protocol ID
- China-2021-01
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study did not enrol
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension in Ethnic Chinese Population The Zhuiguang Trial
- ClinicalTrials.gov ID
- NCT05043831
- Acronym / sponsor ID
- China-2021-01
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study didnt start and will be re-designed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BelkinVisionIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 14 Sep 2021 (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.
The objective of this study is to evaluate the effectiveness (Intra-Ocular Pressure lowering) and safety of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese subjects with Primary Open Angle Glaucoma or Ocular Hypertension.
Detailed description
Glaucoma, which is very common disease in China, can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is.
The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT in ethnic Chinese population and determine that it is as effective in reducing intraocular pressure.
DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list.
Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT) | Experimental | Device: DSLTSubjects will be treated with DSLT |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Device: DSLTSubjects will be treated with SLT |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 years or older, any gender, of Chinese Han ethnicity, with corrected visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension.
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants.
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
Key exclusion criteria (26 listed)
- Contraindications to conventional laser trabeculoplasty (e.g., corneal abnormalities, etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
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 |
|---|---|---|
| DSLTAlso: SLTDirect-SLT is applied via the limbus to the trabecular meshwork | Device | Direct Selective Laser Trabeculoplasty (DSLT), Selective Laser Trabeculoplasty (SLT) |
Primary outcome
IOP reduction from baseline to 6 months
Time frame: 6 months
The primary effectiveness endpoint is the difference between the two treatment groups' change-from-baseline IOP, where change-from-baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at 6 months for each subject.
5 secondary outcomes
Mean percentage IOP reduction
Time frame: 3, 6, 12 months
Subjects with at least 20% IOP reduction
Time frame: 6 months
Change in medications
Time frame: 12 months
Treatment failures
Time frame: r months
Adverse events
Time frame: 6, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No. Study did not enrol
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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.
Sun Xinghuai, Prof. principal investigator
Fundan University, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing DSLT in people with Glaucoma, Open-Angle and Ocular Hypertension, run by BelkinVision.
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 7 inclusion and 26 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: withdrawn, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP reduction from baseline to 6 months (time frame: 6 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 12 May 2023.