NCT06184620

Brief Summary

The goal of this observational study is to discuss the correlation between primary angle-closure glaucoma and the state of the suspended ligament of the lens and the pathogenesis of PACG by measuring the biological data of primary angle-closure glaucoma and observing its anatomical changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

December 14, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

primary angle closure glaucomaUBMlens zonule

Outcome Measures

Primary Outcomes (2)

  • Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),

    Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),

    before operation

  • Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions

    Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions

    before operation

Study Arms (2)

PACG group

All patients in the experimental group met the diagnostic criteria of primary angle-closure glaucoma in the Chinese Glaucoma Guidelines(2020).

control group

The depth of the anterior chamber is normal, and the whole corner of the chamber is open; The cup-to-plate ratio is less than 0.5; No family history of glaucoma

Eligibility Criteria

Age47 Years - 91 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From December 2020 to January 2022, patients with primary angle-closure glaucoma and normal control patients were diagnosed for the first time and intended to undergo cataract surgery in the ophthalmology department of the First Affiliated Hospital of Shandong First Medical University (Shandong Qiandfo Hospital).

You may qualify if:

  • The depth of the anterior chamber is normal, and the whole corner of the chamber is open;
  • The cup-to-plate ratio is less than 0.5;
  • No family history of glaucoma.

You may not qualify if:

  • Previous history of trauma or internal eye surgery in both eyes or one eye;
  • Used "pilocarpine", "atropine" and other drugs to change the size of the pupil and the shape of the chamber Angle within 1 week;
  • Combined with other eye diseases affecting the Angle and suspension ligament, such as uveitis, ciliary cyst, high myopia, retinal diseases, etc.;
  • Can not cooperate with UBM and Angle scopy;
  • Refuse to participate in this researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

guangfu Dang

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 28, 2023

Study Start

December 1, 2020

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations