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

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ClinicalTrials.gov Identifier: NCT05163093
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Chunyan Qiao_2021, Beijing Tongren Hospital

Study Description
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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.

Condition or disease
Angle-Closure Glaucoma

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:

  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.
Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research on the Diagnosis and Treatment of Angle Closure Glaucoma With Abnormal Lens Zonular
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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Group/Cohort
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. visual acuity (VA) [ Time Frame: baseline ]
    best corrected visual acuity (BCVA)

  2. visual acuity (VA) [ Time Frame: during the procedure ]
    best corrected visual acuity (BCVA)

  3. intraocular pressure (IOP) [ Time Frame: baseline ]
    non-contact tenometer

  4. intraocular pressure (IOP) [ Time Frame: during the procedure ]
    non-contact tenometer

  5. slit-lamp examination [ Time Frame: baseline ]
    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

  6. slit-lamp examination [ Time Frame: during the procedure ]
    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

  7. gonioscopy [ Time Frame: baseline ]
    Observe the range of peripheral anaterior synechia by gonioscopy

  8. gonioscopy [ Time Frame: during the procedure ]
    Observe the range of peripheral anaterior synechia by gonioscopy

  9. IOL Master 700 [ Time Frame: baseline ]
    Assess the anterior chamber depth (ACD)

  10. IOL Master 700 [ Time Frame: baseline ]
    lens thickness (LT)

  11. IOL Master 700 [ Time Frame: baseline ]
    axial length (AL)

  12. IOL Master 700 [ Time Frame: baseline ]
    calculate lens position(LP). LP=ACD+1/2LT.

  13. IOL Master 700 [ Time Frame: baseline ]
    relative lens position. RLP=LP/AL.

  14. IOL Master 700 [ Time Frame: during the procedure (before bend test) ]
    Assess the anterior chamber depth (ACD)

  15. IOL Master 700 [ Time Frame: during the procedure (before bend test) ]
    lens thickness (LT)

  16. IOL Master 700 [ Time Frame: during the procedure (before bend test) ]
    axial length (AL)

  17. IOL Master 700 [ Time Frame: during the procedure (before bend test) ]
    calculate lens position(LP). LP=ACD+1／2LT.

  18. IOL Master 700 [ Time Frame: during the procedure (before bend test) ]
    relative lens position. RLP=LP/AL.

  19. IOL Master 700 [ Time Frame: during the procedure (after bend test) ]
    Assess the anterior chamber depth (ACD)

  20. IOL Master 700 [ Time Frame: during the procedure (after bend test) ]
    lens thickness (LT)

  21. IOL Master 700 [ Time Frame: during the procedure (after bend test) ]
    axial length (AL)

  22. IOL Master 700 [ Time Frame: during the procedure (after bend test) ]
    calculate lens position(LP). LP=ACD+1／2LT.

  23. IOL Master 700 [ Time Frame: during the procedure (after bend test) ]
    relative lens position. RLP=LP/AL.

  24. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Assess the ACD

  25. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    angle opening distance (AOD)

  26. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    trabecular-iris space area (TISA)

  27. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    angle recess area (ARA)

  28. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    iris-trabecular index of contact (ITIC)

  29. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Front R

  30. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Back R

  31. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Tilt

  32. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Lens thickness (LT)

  33. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    Decent

  34. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    LE-Dia

  35. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: baseline ]
    lens vault (LV)

  36. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Assess the ACD

  37. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    angle opening distance (AOD)

  38. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    trabecular-iris space area (TISA)

  39. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    angle recess area (ARA)

  40. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    iris-trabecular index of contact (ITIC)

  41. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Front R

  42. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Back R

  43. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Tilt

  44. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Lens thickness (LT)

  45. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    Decent

  46. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    LE-Dia

  47. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (before bend test) ]
    lens vault (LV)

  48. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Assess the ACD

  49. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    angle opening distance (AOD)

  50. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    trabecular-iris space area (TISA)

  51. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    angle recess area (ARA)

  52. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    iris-trabecular index of contact (ITIC)

  53. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Front R

  54. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Back R

  55. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Tilt

  56. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Lens thickness (LT)

  57. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    Decent

  58. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    LE-Dia

  59. CAISA 2 anterior segment optical coherence tomography (AS-OCT) [ Time Frame: during the procedure (after bend test) ]
    lens vault (LV)

  60. 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.

  61. 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.

  62. 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.


Biospecimen Retention:   Samples With DNA
Lens capsule

Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. And 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.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163093


Contacts
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Contact: Chunyan Qiao, MD 86-176-1067-8637 chunyan_qiao@163.com

Locations
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China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Chunyan Qiao_2021
More Information
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Responsible Party: Chunyan Qiao_2021, Ophthalmologist, Chief of out-patient department, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT05163093    
Other Study ID Numbers: Angle closure glaucoma
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chunyan Qiao_2021, Beijing Tongren Hospital:
angle closure glaucoma
lens subluxation
zonular
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases