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Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

DSLT

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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%)
Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
1. A visual field MD of worse than -12dB
2. 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.
3. At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
4. 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct Selective Laser Trabeculoplasty (DSLT)

Selective Laser Trabeculoplasty (SLT)

Arm Description

Subjects will be treated with DSLT

Subjects will be treated with SLT

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean percentage IOP reduction

Mean percentage reduction in IOP at 3, 6 and 12 months.

Subjects with at least 20% IOP reduction

Proportion of subjects with at least 20% reduction in IOP from baseline

Change in medications

Number of glaucoma medications at 12 months as compared to screening/visit 1 (before treatment) and compared between groups.

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).

Adverse events

Proportion of ocular adverse events between the 2 arms at 6 and 12 months

Full Information

NCT ID

NCT05043831

First Posted

August 30, 2021

Last Updated

May 11, 2023

Sponsor

BelkinVision

1. Study Identification

Unique Protocol Identification Number

NCT05043831

Brief Title

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial

Official Title

Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension in Ethnic Chinese Population The Zhuiguang Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Study didnt start and will be re-designed

Study Start Date

October 15, 2021 (Anticipated)

Primary Completion Date

January 15, 2023 (Anticipated)

Study Completion Date

April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BelkinVision

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 randomization

Masking

Outcomes Assessor

Masking Description

Outcome assessor is not aware if subject is treated with SLT or DSLT

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct Selective Laser Trabeculoplasty (DSLT)

Arm Type

Experimental

Arm Description

Subjects will be treated with DSLT

Arm Title

Selective Laser Trabeculoplasty (SLT)

Arm Type

Active Comparator

Arm Description

Subjects will be treated with SLT

Intervention Type

Device

Intervention Name(s)

DSLT

Other Intervention Name(s)

SLT

Intervention Description

Direct-SLT is applied via the limbus to the trabecular meshwork

Primary Outcome Measure Information:

Title

IOP reduction from baseline to 6 months

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Mean percentage IOP reduction

Description

Mean percentage reduction in IOP at 3, 6 and 12 months.

Time Frame

3, 6, 12 months

Title

Subjects with at least 20% IOP reduction

Description

Proportion of subjects with at least 20% reduction in IOP from baseline

Time Frame

6 months

Title

Change in medications

Description

Number of glaucoma medications at 12 months as compared to screening/visit 1 (before treatment) and compared between groups.

Time Frame

12 months

Title

Treatment failures

Description

Time Frame

r months

Title

Adverse events

Description

Proportion of ocular adverse events between the 2 arms at 6 and 12 months

Time Frame

6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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%) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun Xinghuai, Prof.

Organizational Affiliation

Fundan University, Shanghai, China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Study did not enrol

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Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial

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