NCT05163093

Brief Summary

Angle-closure glaucoma is the main type of glaucoma in China, which is divided into acute and chronic angle-closure glaucoma. Previous studies from our group have found that, in lens excision combined with glaucoma surgery, accounted for 46.2% of patients were ligament abnormalities, such as lens subluxation with suspensory ligament relaxation. And it was more common in acute angle-closure glaucoma (55.8%). In acute angle-closure glaucoma, approximately 55.2% of suspensory ligament abnormalities were not diagnosed preoperatively depend on UBM and slit lamp examinations. The purpose of this study was to find a better preoperative diagnosis method of the suspensory ligament abnormality, and to observe the influence of the suspensory ligament abnormality on the occurrence, development and treatment effect of acute angle-closure glaucoma. We plan to collect patients with acute angle-closure glaucoma with monocular onset and exclude traumatic, secondary glaucoma and a history of intraocular surgery. The onset eyes were treated with combined operation, and divided into two groups according to the presence or absence of suspensory ligament abnormalities. The fellow eyes were treated with laser peripheral iridectomy, and followed examination, including UBM, anterior-segment OCT, and IOL master 700, before and after bow excitation test. Then follow up patients every six months. Ultimately, the fellow eyes will be treated with combined surgery after 2.5 years or the fellow eyes occur acute angle-closure glaucoma. In the end, we evaluate the sensitivity and specificity of each index, and the influence of suspensory ligament abnormality on angle-closure glaucoma progression.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

November 7, 2021

Last Update Submit

March 6, 2023

Conditions

Angle-Closure Glaucoma

Keywords

angle closure glaucomalens subluxationzonular

Outcome Measures

Primary Outcomes (62)

  • visual acuity (VA)

    best corrected visual acuity (BCVA)

    baseline

  • visual acuity (VA)

    best corrected visual acuity (BCVA)

    during the procedure

  • intraocular pressure (IOP)

    non-contact tenometer

    baseline

  • intraocular pressure (IOP)

    non-contact tenometer

    during the procedure

  • slit-lamp examination

    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

    baseline

  • slit-lamp examination

    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

    during the procedure

  • gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    baseline

  • gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    during the procedure

  • IOL Master 700

    Assess the anterior chamber depth (ACD)

    baseline

  • IOL Master 700

    lens thickness (LT)

    baseline

  • IOL Master 700

    axial length (AL)

    baseline

  • IOL Master 700

    calculate lens position(LP). LP=ACD+1/2LT.

    baseline

  • IOL Master 700

    relative lens position. RLP=LP/AL.

    baseline

  • IOL Master 700

    Assess the anterior chamber depth (ACD)

    during the procedure (before bend test)

  • IOL Master 700

    lens thickness (LT)

    during the procedure (before bend test)

  • IOL Master 700

    axial length (AL)

    during the procedure (before bend test)

  • IOL Master 700

    calculate lens position(LP). LP=ACD+1／2LT.

    during the procedure (before bend test)

  • IOL Master 700

    relative lens position. RLP=LP/AL.

    during the procedure (before bend test)

  • IOL Master 700

    Assess the anterior chamber depth (ACD)

    during the procedure (after bend test)

  • IOL Master 700

    lens thickness (LT)

    during the procedure (after bend test)

  • IOL Master 700

    axial length (AL)

    during the procedure (after bend test)

  • IOL Master 700

    calculate lens position(LP). LP=ACD+1／2LT.

    during the procedure (after bend test)

  • IOL Master 700

    relative lens position. RLP=LP/AL.

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    baseline

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    during the procedure (before bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    during the procedure (after bend test)

  • CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    during the procedure (after bend test)

  • Ultrasound biomicrospy (UBM)

    Measure the distance between ciliary and the equator of lens, iris-lens angle by using UBM. Collect all the data of 3, 6, 9,12 o'clock position.

    baseline

  • Ultrasound biomicrospy (UBM)

    Measure the distance between ciliary and the equator of lens, iris-lens angle by using UBM. Collect all the data of 3, 6, 9,12 o'clock position.

    during the procedure (before bend test)

  • Ultrasound biomicrospy (UBM)

    Measure the distance between ciliary and the equator of lens, iris-lens angle by using UBM. Collect all the data of 3, 6, 9,12 o'clock position.

    during the procedure (after bend test)

Study Arms (2)

Angle closure glaucoma patients with or without abnormal zonular.

We observe the zonular during surgery, and divide patients into two groups according to their zonular, including with or without abnormal zonular.

Patients with age-related cataract.

We observe the zonular during surgery, and divide patients into two groups according to their zonular, including with or without abnormal zonular.

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Continuous cases diagnose with angle-closure glaucoma in Beijing Tongren Hospital from January 1st, 2022 to December 31th, 2023 and undergo phacoemulsification lens extraction combined with intraocular lens implantation combined with anterior chamber angle separation will be included in the case group. And the patients who are diagnosed age-related cataract and undergo phacoemulsification lens extraction combined with intraocular lens implantation at the same time in Beijing Tongren Hospital will be included as control group.

You may qualify if:

  • age: 45-79 years old, BCVA\>0.3.
  • Clinical diagnosis of angle-closure glaucoma, with 19mm\<axial length\<24mm.
  • Clinical diagnosis of age-related cataract (as control group), with 22mm\<axial length\<26mm.
  • All the surgeries were finished by the same two experienced ophthalmologists.
  • The first operated eye was included for observation.

You may not qualify if:

  • Age-related cataract patients whose anterior chamber depth (ACD)\<2.5mm.
  • Patients who underwent ocular surgery, such as peripheral iridotomy, trabeculectomy.
  • Patients with history of ocular trauma.
  • Patients with other ophthalmic diseases that can cause shallow anterior chamber expect glaucoma and cataract, such as choroid detachment, ciliary body detachment, retinal detachment, bulbar tumor, etc.
  • Secondary glaucoma, such as neovascular glaucoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Lens capsule

MeSH Terms

Conditions

Glaucoma, Angle-ClosureLens Subluxation

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesLens Diseases

Central Study Contacts

Chunyan Qiao, MD

CONTACT

86-176-1067-8637chunyan_qiao@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ophthalmologist, Chief of out-patient department

Study Record Dates

First Submitted

November 7, 2021

First Posted

December 20, 2021

Study Start

November 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

CN(1)