Primary Open Angle GlaucomaZhuiguangzheNCT05902871
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
A study testing External Automatic Glaucoma Laser and Direct Selective Laser Trabeculoplasty in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by BelkinVision at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension, Normal Tension Glaucoma
- What is being tested?
- External Automatic Glaucoma Laser and Direct Selective Laser Trabeculoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Mar 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese ethnicity with corrected visual acuity greater than 6/18 in both eyes.
- Diagnosed with mild to moderate primary open angle glaucoma, ocular hypertension, or normal tension open angle glaucoma.
- Willing and able to participate in a 12-month study, comply with the study procedures, and adhere to the follow-up schedule.
- Capable of giving informed consent.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Eye conditions as specified in the protocol.
- Use of medications as specified in the protocol.
- Unable to provide a reliable visual field test.
- Women who are pregnant or may become pregnant during the study.
- Prior surgery in the study eye.
- In a vision-dependent profession such as pilot or commercial driver.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension and Normal Tension Glaucoma in Ethnic Chinese Population - The Zhuiguangzhe Trial
The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).
Read the detailed description
After informed consent is obtained, potential study participants will undergo a hypotensive medication washout period as applicable. Patients will then be re-assessed for eligibility and treated with DSLT if they meet the inclusion/exclusion criteria. The first 5 patients will be treated 360 degrees with laser energy of 1.2 millijoule (mJ) (Group 1). If all 5 Group 1 patients pass the pre-defined safety endpoint at Week 1, then the next 40 patients will be treated 360 degrees with laser energy of 1.8 mJ (Group 2). Patients will attend one treatment visit and up to 9 follow-up visits, remotely or at the clinic. Individual duration of participation is approximately 12 months.
- Being tested
- External Automatic Glaucoma Laser, Direct Selective Laser Trabeculoplasty
- Keywords
- Glaucoma, High intraocular eye pressure, Normal tension open angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Automatic Glaucoma LaserDevice
Also called Eagle
Trans-limbal, direct selective laser trabeculoplasty (DSLT) instrument that directs laser energy through the sclera around the limbus overlying the trabecular meshwork and treats 360 degrees of the angle is treated simultaneously
Direct Selective Laser TrabeculoplastyProcedure or surgery
Also called DSLT
Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| DSLT with Eagle (Group 1) | Experimental | Single treatment 360 degrees with laser energy of 1.2 mJ Receives: Device: External Automatic Glaucoma Laser; Procedure: Direct Selective Laser Trabeculoplasty |
| DSLT with Eagle (Group 2) | Experimental | Single treatment 360 degrees with laser energy of 1.8 mJ Receives: Device: External Automatic Glaucoma Laser; Procedure: Direct Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in IOP at Month 6
Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). 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 Month 6 for each participant enrolled in the study. A negative change from baseline will represent an improvement.
Measured: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6
Secondary outcomes (3)
Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12
Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). 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 the respective timepoints (Month 6 and Month 12). A positive percent reduction will represent an improvement.
Measured: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
Proportion of Subjects with at least 20 percent reduction in IOP from Baseline in IOP for POAG and OHT and at least 15 percent reduction in IOP for NTG at Month 6 with no Secondary Surgical Intervention (SSI) or Inability to Washout
Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). A secondary surgical intervention (SSI) is defined as a procedure in addition to DSLT that is conducted to manage/lower IOP. A higher proportion with the specified reduction will represent an improvement.
Measured: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12
The number of glaucoma-related medications in use will be recorded. For medicated subjects, the Screening visit is considered baseline. For naïve (unmedicated) subjects, Visit 1 is considered baseline.
Measured: Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start11 Mar 2024
- Primary completion2 Jul 2026
- Study completionJan 2027 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BelkinVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorit Raz Prag, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902871
- Sponsor's protocol ID
- #China-2022-01 (CA-PL-01-008)
- Acronym
- Zhuiguangzhe
- Status last verified
- Aug 2026
- First submitted
- 10 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. 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 and Normal Tension Glaucoma in Ethnic Chinese Population - The Zhuiguangzhe Trial
- ClinicalTrials.gov ID
- NCT05902871
- Acronym / sponsor ID
- Zhuiguangzhe / #China-2022-01 (CA-PL-01-008)
- Keywords
- Glaucoma, High intraocular eye pressure, Normal tension open angle glaucoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BelkinVisionIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Jun 2023 (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 safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).
Detailed description
After informed consent is obtained, potential study participants will undergo a hypotensive medication washout period as applicable. Patients will then be re-assessed for eligibility and treated with DSLT if they meet the inclusion/exclusion criteria. The first 5 patients will be treated 360 degrees with laser energy of 1.2 millijoule (mJ) (Group 1). If all 5 Group 1 patients pass the pre-defined safety endpoint at Week 1, then the next 40 patients will be treated 360 degrees with laser energy of 1.8 mJ (Group 2). Patients will attend one treatment visit and up to 9 follow-up visits, remotely or at the clinic. Individual duration of participation is approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSLT with Eagle (Group 1) | Experimental | Device: External Automatic Glaucoma Laser, Procedure: Direct Selective Laser TrabeculoplastySingle treatment 360 degrees with laser energy of 1.2 mJ |
| DSLT with Eagle (Group 2) | Experimental | Device: External Automatic Glaucoma Laser, Procedure: Direct Selective Laser TrabeculoplastySingle treatment 360 degrees with laser energy of 1.8 mJ |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese ethnicity with corrected visual acuity greater than 6/18 in both eyes.
- Diagnosed with mild to moderate primary open angle glaucoma, ocular hypertension, or normal tension open angle glaucoma.
- Willing and able to participate in a 12-month study, comply with the study procedures, and adhere to the follow-up schedule.
- Capable of giving informed consent.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Eye conditions as specified in the protocol.
- Use of medications as specified in the protocol.
- Unable to provide a reliable visual field test.
- Women who are pregnant or may become pregnant during the study.
- Prior surgery 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 |
|---|---|---|
| External Automatic Glaucoma LaserAlso: EagleTrans-limbal, direct selective laser trabeculoplasty (DSLT) instrument that directs laser energy through the sclera around the limbus overlying the trabecular meshwork and treats 360 degrees of the angle is treated simultaneously | Device | DSLT with Eagle (Group 1), DSLT with Eagle (Group 2) |
| Direct Selective Laser TrabeculoplastyAlso: DSLTSurgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure | Procedure or surgery | DSLT with Eagle (Group 1), DSLT with Eagle (Group 2) |
Primary outcome
Mean Change from Baseline in IOP at Month 6
Time frame: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6
Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). 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 Month 6 for each participant enrolled in the study. A negative change from baseline will represent an improvement.
3 secondary outcomes
Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12
Time frame: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
Proportion of Subjects with at least 20 percent reduction in IOP from Baseline in IOP for POAG and OHT and at least 15 percent reduction in IOP for NTG at Month 6 with no Secondary Surgical Intervention (SSI) or Inability to Washout
Time frame: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12
Time frame: Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Dorit Raz Prag study director
Alcon Research, LLC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Automatic Glaucoma Laser and Direct Selective Laser Trabeculoplasty in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by BelkinVision at 2 sites in 2 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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Change from Baseline in IOP at Month 6 (time frame: Baseline (Day -7 to 0) (post washout and pretreatment), Month 6). 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 17 Aug 2026.