NCT05309811

Brief Summary

The purpose of this study is to investigate the effect of repeated low-level red-light therapy on existing visual field damages in primary open-angle glaucoma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 25, 2022

Last Update Submit

March 25, 2022

Conditions

Open Angle GlaucomaEye Diseases

Keywords

Open-angle glaucomaRepeated low-level red-light therapyVisual field

Outcome Measures

Primary Outcomes (1)

  • Changes of mean deviations (MD) in visual field tests

    The twelve-week changes of MD are characterized as differences between the 12-week follow-up visit and the baseline visit or differences between the 24-week visit and the 12-week follow-up visit. The Humphrey Visual Field Analyzer will be used to measure MD (dB).

    12 weeks and 24 weeks

Secondary Outcomes (9)

  • Changes of mean deviations (MD) in visual field tests

    4 weeks and 16 weeks

  • Incidence rates of significant reversal of visual field damages

    4 weeks, 12 weeks, 16 weeks and 24 weeks

  • Changes of pattern standard deviations (PSD) in visual field tests

    4 weeks, 12 weeks, 16 weeks and 24 weeks

  • Changes of the thickness of parapapillary retinal nerve fiber layer

    4 weeks, 12 weeks, 16 weeks and 24 weeks

  • Changes of the thickness of perifoveal ganglion cell-inner plexiform layer

    4 weeks, 12 weeks, 16 weeks and 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

RLRL therapy with routine IOP-lowering medications in the 1st-12th weeks then crossing to only routine IOP-lowering medications in the 13th-24th weeks

Device: RLRL therapyDrug: Routine IOP-lowering medications

Group B

EXPERIMENTAL

Only routine IOP-lowering medications in the 1st-12th weeks then crossing to RLRL therapy with routine IOP-lowering medications in the 13th-24th weeks

Device: RLRL therapyDrug: Routine IOP-lowering medications

Interventions

RLRL therapyDEVICE

Each RLRL treatment lasts three minutes. RLRL treatments will be performed twice a day, with at least four hours between each RLRL treatment.

Also known as: Repeated Low-Level Red-Light Therapy
Group AGroup B
Routine IOP-lowering medicationsDRUG

Medications prescribed for IOP control by glaucoma specialists in the outpatient.

Also known as: Anti-glaucoma medications
Group AGroup B

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-69 years;
  • Diagnosis of primary open-angle glaucoma with definite visual field defects in either eye (MD \<-3dB);
  • Well-controlled IOP in both eyes (IOP\<21mmHg).

You may not qualify if:

  • Severe visual field defects in either eye (MD \<-22dB);
  • Visual field defects caused by other diseases in either eye;
  • Unreliable results of visual field or IOP measurements in either eye;
  • Diagnosis of other ocular diseases in active phase in either eye;
  • History of refractive surgeries in either eye;
  • History of other ophthalmic laser treatments or intraocular surgeries in the last 3 months in either eye;
  • Refusing to inform consents or having difficulties to take part in follow-ups in next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleEye Diseases

Interventions

Antiglaucoma Agents

Condition Hierarchy (Ancestors)

GlaucomaOcular Hypertension

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mingguang He, MD, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingguang He, MD, PhD

CONTACT

8602087331906mingguang_he@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

April 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2023

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)