NCT06340061

Brief Summary

The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 20, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

March 10, 2024

Last Update Submit

March 24, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • IOP

    Intraocular pressure

    through study completion, an average of 2 years.

  • bIOP

    Biomechanical intraocular pressure. Corneal Biomechanics Parameters.

    through study completion, an average of 2 years.

  • ACD

    Anterior chamber depth. Anterior Chamber Parameters.

    through study completion, an average of 2 years.

  • ACW

    Anterior chamber width. Anterior Chamber Parameters.

    through study completion, an average of 2 years.

  • SSI

    Stress-strain index. Corneal Biomechanics Parameters.

    through study completion, an average of 2 years.

  • VF

    visual field. The severity of glaucoma is mainly based on the damage of the visual field

    through study completion, an average of 2 years.

Study Arms (2)

Treatment group

Other: Observational study

Control group

Interventions

The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma

Treatment group

Eligibility Criteria

Age22 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients

You may qualify if:

  • Clinical diagnosis of primary glaucoma.
  • Must be able to cooperate to complete the inspection.

You may not qualify if:

  • Secondary glaucoma.
  • Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.
  • trauma
  • congenital eye malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Observation

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Qian Liu

    Henan Provincial People's Hospital, Henan Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2024

First Posted

April 1, 2024

Study Start

October 20, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations