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Status unknownNCT05163093Updated Mar 7, 2023

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

An observational study in Angle-Closure Glaucoma, sponsored by Chunyan Qiao_2021. Status unknown at 1 site in China. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Chunyan Qiao_2021 · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
45 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.
  1. 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.
02

Conditions studied

  • Angle-Closure Glaucoma

Keywords

  • angle closure glaucoma
  • lens subluxation
  • zonular
03

In context

Glaucoma, Angle-Closure

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's planned enrollment of 250 is above the median of 225 across 32 observational studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

This is the only study on the registry with Chunyan Qiao_2021 as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 79 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. visual acuity (VA)

    best corrected visual acuity (BCVA)

    Time frame: baseline

  2. visual acuity (VA)

    best corrected visual acuity (BCVA)

    Time frame: during the procedure

  3. intraocular pressure (IOP)

    non-contact tenometer

    Time frame: baseline

  4. intraocular pressure (IOP)

    non-contact tenometer

    Time frame: during the procedure

  5. slit-lamp examination

    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

    Time frame: baseline

  6. slit-lamp examination

    Assess the condition of ACD and lens iris septum tremors by slit-lamp examination

    Time frame: during the procedure

  7. gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    Time frame: baseline

  8. gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    Time frame: during the procedure

  9. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Time frame: baseline

  10. IOL Master 700

    lens thickness (LT)

    Time frame: baseline

  11. IOL Master 700

    axial length (AL)

    Time frame: baseline

  12. IOL Master 700

    calculate lens position(LP). LP=ACD+1/2LT.

    Time frame: baseline

  13. IOL Master 700

    relative lens position. RLP=LP/AL.

    Time frame: baseline

  14. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Time frame: during the procedure (before bend test)

  15. IOL Master 700

    lens thickness (LT)

    Time frame: during the procedure (before bend test)

  16. IOL Master 700

    axial length (AL)

    Time frame: during the procedure (before bend test)

  17. IOL Master 700

    calculate lens position(LP). LP=ACD+1／2LT.

    Time frame: during the procedure (before bend test)

  18. IOL Master 700

    relative lens position. RLP=LP/AL.

    Time frame: during the procedure (before bend test)

  19. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Time frame: during the procedure (after bend test)

  20. IOL Master 700

    lens thickness (LT)

    Time frame: during the procedure (after bend test)

  21. IOL Master 700

    axial length (AL)

    Time frame: during the procedure (after bend test)

  22. IOL Master 700

    calculate lens position(LP). LP=ACD+1／2LT.

    Time frame: during the procedure (after bend test)

  23. IOL Master 700

    relative lens position. RLP=LP/AL.

    Time frame: during the procedure (after bend test)

  24. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    Time frame: baseline

  25. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    Time frame: baseline

  26. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    Time frame: baseline

  27. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    Time frame: baseline

  28. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    Time frame: baseline

  29. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    Time frame: baseline

  30. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    Time frame: baseline

  31. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    Time frame: baseline

  32. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    Time frame: baseline

  33. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    Time frame: baseline

  34. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    Time frame: baseline

  35. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    Time frame: baseline

  36. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    Time frame: during the procedure (before bend test)

  37. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    Time frame: during the procedure (before bend test)

  38. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    Time frame: during the procedure (before bend test)

  39. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    Time frame: during the procedure (before bend test)

  40. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    Time frame: during the procedure (before bend test)

  41. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    Time frame: during the procedure (before bend test)

  42. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    Time frame: during the procedure (before bend test)

  43. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    Time frame: during the procedure (before bend test)

  44. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    Time frame: during the procedure (before bend test)

  45. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    Time frame: during the procedure (before bend test)

  46. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    Time frame: during the procedure (before bend test)

  47. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    Time frame: during the procedure (before bend test)

  48. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Assess the ACD

    Time frame: during the procedure (after bend test)

  49. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle opening distance (AOD)

    Time frame: during the procedure (after bend test)

  50. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    trabecular-iris space area (TISA)

    Time frame: during the procedure (after bend test)

  51. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    angle recess area (ARA)

    Time frame: during the procedure (after bend test)

  52. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    iris-trabecular index of contact (ITIC)

    Time frame: during the procedure (after bend test)

  53. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Front R

    Time frame: during the procedure (after bend test)

  54. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Back R

    Time frame: during the procedure (after bend test)

  55. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Tilt

    Time frame: during the procedure (after bend test)

  56. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Lens thickness (LT)

    Time frame: during the procedure (after bend test)

  57. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    Decent

    Time frame: during the procedure (after bend test)

  58. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    LE-Dia

    Time frame: during the procedure (after bend test)

  59. CAISA 2 anterior segment optical coherence tomography (AS-OCT)

    lens vault (LV)

    Time frame: during the procedure (after bend test)

  60. 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.

    Time frame: baseline

  61. 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.

    Time frame: during the procedure (before bend test)

  62. 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.

    Time frame: during the procedure (after bend test)

07

Study locations

1 of 1 sites recruiting
  • Beijing Tongren Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05163093
Lead sponsor
Chunyan Qiao_2021
Responsible party
Chunyan Qiao_2021 (Ophthalmologist, Chief of out-patient department, Beijing Tongren Hospital) — Sponsor-investigator
First posted
Dec 20, 2021
Start date
Nov 1, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 7, 2023

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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