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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05163093
Other study ID # Angle closure glaucoma
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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