- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05163093
Research on the Diagnosis and Treatment of Angle Closure Glaucoma With Abnormal Lens Zonular
Study Overview
Status
Conditions
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:
- angle-closure glaucoma (ACG): a. Both eyes with shallow anterior chamber (ACD<2.5mm). b. With short axial length (axial length<24mm).
- 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
- . 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.
- .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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chunyan Qiao, MD
- Phone Number: 86-176-1067-8637
- Email: chunyan_qiao@163.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual acuity (VA)
Time Frame: baseline
|
best corrected visual acuity (BCVA)
|
baseline
|
visual acuity (VA)
Time Frame: during the procedure
|
best corrected visual acuity (BCVA)
|
during the procedure
|
intraocular pressure (IOP)
Time Frame: baseline
|
non-contact tenometer
|
baseline
|
intraocular pressure (IOP)
Time Frame: during the procedure
|
non-contact tenometer
|
during the procedure
|
slit-lamp examination
Time Frame: baseline
|
Assess the condition of ACD and lens iris septum tremors by slit-lamp examination
|
baseline
|
slit-lamp examination
Time Frame: during the procedure
|
Assess the condition of ACD and lens iris septum tremors by slit-lamp examination
|
during the procedure
|
gonioscopy
Time Frame: baseline
|
Observe the range of peripheral anaterior synechia by gonioscopy
|
baseline
|
gonioscopy
Time Frame: during the procedure
|
Observe the range of peripheral anaterior synechia by gonioscopy
|
during the procedure
|
IOL Master 700
Time Frame: baseline
|
Assess the anterior chamber depth (ACD)
|
baseline
|
IOL Master 700
Time Frame: baseline
|
lens thickness (LT)
|
baseline
|
IOL Master 700
Time Frame: baseline
|
axial length (AL)
|
baseline
|
IOL Master 700
Time Frame: baseline
|
calculate lens position(LP).
LP=ACD+1/2LT.
|
baseline
|
IOL Master 700
Time Frame: baseline
|
relative lens position.
RLP=LP/AL.
|
baseline
|
IOL Master 700
Time Frame: during the procedure (before bend test)
|
Assess the anterior chamber depth (ACD)
|
during the procedure (before bend test)
|
IOL Master 700
Time Frame: during the procedure (before bend test)
|
lens thickness (LT)
|
during the procedure (before bend test)
|
IOL Master 700
Time Frame: during the procedure (before bend test)
|
axial length (AL)
|
during the procedure (before bend test)
|
IOL Master 700
Time Frame: during the procedure (before bend test)
|
calculate lens position(LP).
LP=ACD+1/2LT.
|
during the procedure (before bend test)
|
IOL Master 700
Time Frame: during the procedure (before bend test)
|
relative lens position.
RLP=LP/AL.
|
during the procedure (before bend test)
|
IOL Master 700
Time Frame: during the procedure (after bend test)
|
Assess the anterior chamber depth (ACD)
|
during the procedure (after bend test)
|
IOL Master 700
Time Frame: during the procedure (after bend test)
|
lens thickness (LT)
|
during the procedure (after bend test)
|
IOL Master 700
Time Frame: during the procedure (after bend test)
|
axial length (AL)
|
during the procedure (after bend test)
|
IOL Master 700
Time Frame: during the procedure (after bend test)
|
calculate lens position(LP).
LP=ACD+1/2LT.
|
during the procedure (after bend test)
|
IOL Master 700
Time Frame: during the procedure (after bend test)
|
relative lens position.
RLP=LP/AL.
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Assess the ACD
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
angle opening distance (AOD)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
trabecular-iris space area (TISA)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
angle recess area (ARA)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
iris-trabecular index of contact (ITIC)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Front R
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Back R
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Tilt
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Lens thickness (LT)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
Decent
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
LE-Dia
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: baseline
|
lens vault (LV)
|
baseline
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Assess the ACD
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
angle opening distance (AOD)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
trabecular-iris space area (TISA)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
angle recess area (ARA)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
iris-trabecular index of contact (ITIC)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Front R
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Back R
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Tilt
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Lens thickness (LT)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
Decent
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
LE-Dia
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (before bend test)
|
lens vault (LV)
|
during the procedure (before bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Assess the ACD
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
angle opening distance (AOD)
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
trabecular-iris space area (TISA)
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
angle recess area (ARA)
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
iris-trabecular index of contact (ITIC)
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Front R
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Back R
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Tilt
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Lens thickness (LT)
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
Decent
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
LE-Dia
|
during the procedure (after bend test)
|
CAISA 2 anterior segment optical coherence tomography (AS-OCT)
Time Frame: during the procedure (after bend test)
|
lens vault (LV)
|
during the procedure (after bend test)
|
Ultrasound biomicrospy (UBM)
Time Frame: baseline
|
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)
Time Frame: during the procedure (before 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.
|
during the procedure (before bend test)
|
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.
|
during the procedure (after bend test)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Angle closure glaucoma
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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