NCT05043831

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 12, 2023

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 30, 2021

Last Update Submit

May 11, 2023

Conditions

Glaucoma, Open-AngleOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (5)

  • Mean percentage IOP reduction

    3, 6, 12 months

  • Subjects with at least 20% IOP reduction

    6 months

  • Change in medications

    12 months

  • Treatment failures

    r months

  • Adverse events

    6, 12 months

Study Arms (2)

Direct Selective Laser Trabeculoplasty (DSLT)

EXPERIMENTAL

Subjects will be treated with DSLT

Device: DSLT

Selective Laser Trabeculoplasty (SLT)

ACTIVE COMPARATOR

Subjects will be treated with SLT

Device: DSLT

Interventions

DSLTDEVICE

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

Also known as: SLT
Direct Selective Laser Trabeculoplasty (DSLT)Selective Laser Trabeculoplasty (SLT)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Sun Xinghuai, Prof.

    Fundan University, Shanghai, China

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor is not aware if subject is treated with SLT or DSLT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 14, 2021

Study Start

October 15, 2021

Primary Completion

January 15, 2023

Study Completion

April 15, 2023

Last Updated

May 12, 2023

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Study did not enrol