Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial

Last updated: May 11, 2023
Sponsor: BelkinVision
Overall Status: Trial Not Available

Phase

N/A

Condition

Circulation Disorders

Glaucoma

Williams Syndrome

Treatment

DSLT

Clinical Study ID

NCT05043831
China-2021-01
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 40 years or older, any gender, of Chinese Han ethnicity, with corrected visualacuity > 6/60 in both eyes
  2. Open angle glaucoma including exfoliative or pigmentary glaucoma or ocularhypertension.
  3. IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications) forparticipants.
  4. Gonioscopically visible scleral spur for 360 degrees without indentation
  5. Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
  6. Willing and able to participate in the 12-month study, to comply with the studyprocedures and to adhere to the follow-up schedule.
  7. Participant capable of giving informed consent

Exclusion

Exclusion Criteria:

  1. Contraindications to conventional laser trabeculoplasty (e.g., corneal abnormalities,etc.)
  2. Angle Closure Glaucoma
  3. Congenital or developmental glaucoma
  4. Secondary glaucoma except exfoliative or pigmentary glaucoma
  5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
  6. Inability to conduct a reliable visual field (defined as fixation losses, falsepositives or false negatives greater than 33%)
  7. Any of the following visual field findings using the Humphrey visual field analyzerthe SITA-standard 24-2 program:
  8. A visual field MD of worse than -12dB
  9. Greater than or equal to 75% of points depressed below the 5% level and greaterthan or equal to 50% of points depressed below the 1% level on the PD plot.
  10. At least 50% of points (i.e 2 or more) within the central 5 degrees with asensitivity ≤0dB on the decibel plot
  11. Points within the central 5 degrees of fixation with a sensitivity <15 dB in bothhemifields on the decibel plot
  12. A visual field MD of worse than -12dB in the fellow eye
  13. Cup:Disc Ratio of more than 0.8
  14. More than three hypotensive medications required (combination drops are considered as 2 medications)
  15. Prior incisional or laser glaucoma surgery (including previous SLT or LPI) in thestudy eye.
  16. Prior corneal refractive surgery
  17. Complicated cataract surgery ≤ 6 months prior to enrollment
  18. Presence of visually significant cataract in the opinion of the investigator
  19. Clinically significant disease in either eye as determined by the Investigator.
  20. Clinically significant amblyopia in either eye
  21. Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
  22. Women who are pregnant or may become pregnant during the course of the study.
  23. In the opinion of the investigator the participant might require other ocular surgerywithin the 12-month follow-up period, unless for further reduction of their IOP
  24. Concurrent treatment with topical, nasal, inhaled or systemic steroids.
  25. Uncontrolled systemic disease that could impact the ability of the participant toattend follow up visits as per the discretion of the investigator.
  26. Participation in another clinical study, not including a GLAUrious sub-study

Study Design

Treatment Group(s): 1
Primary Treatment: DSLT
Phase:
Study Start date:
October 15, 2021
Estimated Completion Date:
April 15, 2023

Study 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.