Angle-Closure Glaucoma Clinical Trial
Official title:
Research on the Diagnosis and Treatment of Angle Closure Glaucoma With Abnormal Lens Zonular
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tongren Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chunyan Qiao_2021 |
China,
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) |
Status | Clinical Trial | Phase | |
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