NCT04943107

Brief Summary

It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. In order to explore whether antihypertensive medications would influence the neuropathy among glaucomatous population, we designed a cross-sectional observational study to analyze the retinal status among glaucoma patients with use of antihypertensive medication.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 29, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

June 16, 2021

Last Update Submit

June 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • retinal nerve fiber layer thickness

    retinal nerve fiber layer thickness measured by optical coherence tomography

    within 3 months from recruitment

Study Arms (4)

healthy control

adults without glaucoma history or hypertension history

Other: no intervention

glaucoma patients

adults with primary glaucoma history; without glaucoma-related operation history; without hypertension history

Other: no intervention

hypertension patients

adults with primary hypertension history; without glaucoma history

Other: no intervention

glaucoma+hypertension

adults with primary glaucoma history and primary hypertension history; without glaucoma-related operation history

Other: no intervention

Interventions

no intervention, only measurement of blood pressure, intraocular pressure, hypertensive history questionnaire, retinal imaging, optical coherence tomography examination etc..

glaucoma patientsglaucoma+hypertensionhealthy controlhypertension patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient from ophthalmology and cardiology clinic

You may qualify if:

  • age no less than 18 years
  • best corrected visual acuity better than decimal 0.3

You may not qualify if:

  • secondary glaucoma
  • secondary hypertension
  • glaucoma-related operation history
  • pregnancy or lactation period
  • uncooperative with retinal examination
  • severe opacity with refracting media in eye
  • severe retinal diseases and neuropathy
  • congenital retinal optic nerve abnormality
  • other systemic diseases that influence hypertension and glaucoma assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Kaijun Wang, MD

    Second Affiliated Hospital of College of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaijun Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 29, 2021

Study Start

May 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

June 29, 2021

Record last verified: 2021-05

Locations