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

Angle-Closure Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163093
• Other study ID #: Angle closure glaucoma
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Beijing Tongren Hospital
• Contact: Chunyan Qiao, MD
• Phone: 86-176-1067-8637
• Email: chunyan_qiao[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

1.Inclusion criteria:

(1)age: 45-79 years old, BCVA>0.3, 19mmaxial 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:

1. angle-closure glaucoma (ACG): a. Both eyes with shallow anterior chamber (ACD<2.5mm). b. With short axial length (axial length<24mm).

2. acute angle-closure glaucoma (AACG): a. Both eyes with ACG characteristic anatomical structure, including shallow anterior chamber and short axial length. b.Patients with classic history of acute episode, acute elevated intraocular pressure, and atrioscopy or ultrasound biomicroscope (UBM) examination indicated angle closure. c. Ocular examination showed the characteristic changes of acute ocular hypertension: iris atrophy, dilated pupil, glaucoma spot, and pigmented Kp.

4. Diagnostic criteria for lens suspensory ligament abnormalities

1. . Pre-operation: a. UBM shows the distance from ciliary processes to the equatorial part of lens varies in different directions. b. ACD are different between the two eyes and/or lens iris septum tremors by slit-lamp examination.

2. .Intraoperation: a. Suspensory ligament relaxation: with obvious radial folds on lens anterior capsules during continuous circular capsulorhexis (CCC), and could not observe the equator of lens. b. Rupture of suspensory ligament: could observe the equator of lens after full dilation of the pupil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

Inclusion criteria:

1. age: 45-79 years old, BCVA>0.3.

2. Clinical diagnosis of angle-closure glaucoma, with 19mm<axial length<24mm.

3. Clinical diagnosis of age-related cataract (as control group), with 22mm<axial length<26mm.

4. All the surgeries were finished by the same two experienced ophthalmologists.

5. The first operated eye was included for observation.

Exclusion criteria:

1. Age-related cataract patients whose anterior chamber depth (ACD)<2.5mm.

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.

Related Conditions & MeSH terms

• Angle-Closure Glaucoma
• Glaucoma
• Glaucoma, Angle-Closure

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chunyan Qiao_2021

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity (VA)	best corrected visual acuity (BCVA)	baseline
Primary	visual acuity (VA)	best corrected visual acuity (BCVA)	during the procedure
Primary	intraocular pressure (IOP)	non-contact tenometer	baseline
Primary	intraocular pressure (IOP)	non-contact tenometer	during the procedure
Primary	slit-lamp examination	Assess the condition of ACD and lens iris septum tremors by slit-lamp examination	baseline
Primary	slit-lamp examination	Assess the condition of ACD and lens iris septum tremors by slit-lamp examination	during the procedure
Primary	gonioscopy	Observe the range of peripheral anaterior synechia by gonioscopy	baseline
Primary	gonioscopy	Observe the range of peripheral anaterior synechia by gonioscopy	during the procedure
Primary	IOL Master 700	Assess the anterior chamber depth (ACD)	baseline
Primary	IOL Master 700	lens thickness (LT)	baseline
Primary	IOL Master 700	axial length (AL)	baseline
Primary	IOL Master 700	calculate lens position(LP). LP=ACD+1/2LT.	baseline
Primary	IOL Master 700	relative lens position. RLP=LP/AL.	baseline
Primary	IOL Master 700	Assess the anterior chamber depth (ACD)	during the procedure (before bend test)
Primary	IOL Master 700	lens thickness (LT)	during the procedure (before bend test)
Primary	IOL Master 700	axial length (AL)	during the procedure (before bend test)
Primary	IOL Master 700	calculate lens position(LP). LP=ACD+1/2LT.	during the procedure (before bend test)
Primary	IOL Master 700	relative lens position. RLP=LP/AL.	during the procedure (before bend test)
Primary	IOL Master 700	Assess the anterior chamber depth (ACD)	during the procedure (after bend test)
Primary	IOL Master 700	lens thickness (LT)	during the procedure (after bend test)
Primary	IOL Master 700	axial length (AL)	during the procedure (after bend test)
Primary	IOL Master 700	calculate lens position(LP). LP=ACD+1/2LT.	during the procedure (after bend test)
Primary	IOL Master 700	relative lens position. RLP=LP/AL.	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Assess the ACD	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle opening distance (AOD)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	trabecular-iris space area (TISA)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle recess area (ARA)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	iris-trabecular index of contact (ITIC)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Front R	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Back R	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Tilt	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Lens thickness (LT)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Decent	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	LE-Dia	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	lens vault (LV)	baseline
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Assess the ACD	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle opening distance (AOD)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	trabecular-iris space area (TISA)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle recess area (ARA)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	iris-trabecular index of contact (ITIC)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Front R	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Back R	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Tilt	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Lens thickness (LT)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Decent	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	LE-Dia	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	lens vault (LV)	during the procedure (before bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Assess the ACD	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle opening distance (AOD)	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	trabecular-iris space area (TISA)	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	angle recess area (ARA)	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	iris-trabecular index of contact (ITIC)	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Front R	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Back R	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Tilt	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Lens thickness (LT)	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	Decent	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	LE-Dia	during the procedure (after bend test)
Primary	CAISA 2 anterior segment optical coherence tomography (AS-OCT)	lens vault (LV)	during the procedure (after bend test)
Primary	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
Primary	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)
Primary	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)