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Clinical Trials/NCT05163093
NCT05163093RecruitingNot Applicable

Research on the Diagnosis and Treatment of Angle Closure Glaucoma With Abnormal Lens Zonular

Chunyan Qiao_20211 site in 1 country250 target enrollmentStarted: November 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
250
Locations
1
Primary Endpoint
CAISA 2 anterior segment optical coherence tomography (AS-OCT)

Study Overview

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.

Detailed Description

1.Inclusion criteria:

(1)age: 45-79 years old, BCVA>0.3, 19mm<axial length<24mm. (2).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. (3). 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. (4). All the surgeries were finished by the same two experienced ophthalmologists. (5). Both eyes will be undergo with surgery, and we will include the first eye for observation.

2.Exclusion critieria:

(1)Age-related cataract patients whose anterior chamber depth (ACD)<2.5mm, 22mm>axial length, or axial length>26mm. (2).Patients who underwent ocular surgery, such as peripheral iridotomy, trabeculectomy. (3). Patients with history of ocular trauma. (4).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. (5). Secondary glaucoma, such as neovascular glaucoma.

3.Diagnostic critieria:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
45 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: during the procedure (after bend test)

lens vault (LV)

slit-lamp examination

Time Frame: during the procedure

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

IOL Master 700

Time Frame: during the procedure (after bend test)

relative lens position. RLP=LP/AL.

Ultrasound biomicrospy (UBM)

Time Frame: during the procedure (after bend test)

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.

visual acuity (VA)

Time Frame: during the procedure

best corrected visual acuity (BCVA)

intraocular pressure (IOP)

Time Frame: during the procedure

non-contact tenometer

gonioscopy

Time Frame: during the procedure

Observe the range of peripheral anaterior synechia by gonioscopy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chunyan Qiao_2021
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Chunyan Qiao_2021

Ophthalmologist, Chief of out-patient department

Beijing Tongren Hospital

Study Sites (1)

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