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Angle-Closure GlaucomaNCT05163093

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

An observational study of Angle-Closure Glaucoma, run by Chunyan Qiao_2021 at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 45 to 79 years
Conditions the study is for
Angle-Closure Glaucoma
How many people
250 participants
Where
1 siteChina
Study dates
1 Nov 2020to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chunyan Qiao, MD contact

86-176-1067-8637

chunyan_qiao@163.com

China1 site, 1 recruiting

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

Other trials in China

About this study

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.
  3. Diagnostic criteria for lens suspensory ligament abnormalities
  4. . 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.
  5. .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.
Keywords
angle closure glaucoma, lens subluxation, zonular
Medical subject headings
Glaucoma, Angle-Closure, Lens Subluxation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05163093
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. visual acuity (VA)

    best corrected visual acuity (BCVA)

    Measured: baseline

  2. visual acuity (VA)

    best corrected visual acuity (BCVA)

    Measured: during the procedure

  3. intraocular pressure (IOP)

    non-contact tenometer

    Measured: baseline

  4. intraocular pressure (IOP)

    non-contact tenometer

    Measured: during the procedure

  5. slit-lamp examination

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

    Measured: baseline

  6. slit-lamp examination

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

    Measured: during the procedure

  7. gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    Measured: baseline

  8. gonioscopy

    Observe the range of peripheral anaterior synechia by gonioscopy

    Measured: during the procedure

  9. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Measured: baseline

  10. IOL Master 700

    lens thickness (LT)

    Measured: baseline

  11. IOL Master 700

    axial length (AL)

    Measured: baseline

  12. IOL Master 700

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

    Measured: baseline

  13. IOL Master 700

    relative lens position. RLP=LP/AL.

    Measured: baseline

  14. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Measured: during the procedure (before bend test)

  15. IOL Master 700

    lens thickness (LT)

    Measured: during the procedure (before bend test)

  16. IOL Master 700

    axial length (AL)

    Measured: during the procedure (before bend test)

  17. IOL Master 700

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

    Measured: during the procedure (before bend test)

  18. IOL Master 700

    relative lens position. RLP=LP/AL.

    Measured: during the procedure (before bend test)

  19. IOL Master 700

    Assess the anterior chamber depth (ACD)

    Measured: during the procedure (after bend test)

  20. IOL Master 700

    lens thickness (LT)

    Measured: during the procedure (after bend test)

  21. IOL Master 700

    axial length (AL)

    Measured: during the procedure (after bend test)

  22. IOL Master 700

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

    Measured: during the procedure (after bend test)

  23. IOL Master 700

    relative lens position. RLP=LP/AL.

    Measured: during the procedure (after bend test)

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

    Assess the ACD

    Measured: baseline

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

    angle opening distance (AOD)

    Measured: baseline

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

    trabecular-iris space area (TISA)

    Measured: baseline

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

    angle recess area (ARA)

    Measured: baseline

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

    iris-trabecular index of contact (ITIC)

    Measured: baseline

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

    Front R

    Measured: baseline

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

    Back R

    Measured: baseline

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

    Tilt

    Measured: baseline

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

    Lens thickness (LT)

    Measured: baseline

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

    Decent

    Measured: baseline

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

    LE-Dia

    Measured: baseline

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

    lens vault (LV)

    Measured: baseline

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

    Assess the ACD

    Measured: during the procedure (before bend test)

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

    angle opening distance (AOD)

    Measured: during the procedure (before bend test)

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

    trabecular-iris space area (TISA)

    Measured: during the procedure (before bend test)

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

    angle recess area (ARA)

    Measured: during the procedure (before bend test)

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

    iris-trabecular index of contact (ITIC)

    Measured: during the procedure (before bend test)

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

    Front R

    Measured: during the procedure (before bend test)

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

    Back R

    Measured: during the procedure (before bend test)

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

    Tilt

    Measured: during the procedure (before bend test)

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

    Lens thickness (LT)

    Measured: during the procedure (before bend test)

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

    Decent

    Measured: during the procedure (before bend test)

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

    LE-Dia

    Measured: during the procedure (before bend test)

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

    lens vault (LV)

    Measured: during the procedure (before bend test)

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

    Assess the ACD

    Measured: during the procedure (after bend test)

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

    angle opening distance (AOD)

    Measured: during the procedure (after bend test)

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

    trabecular-iris space area (TISA)

    Measured: during the procedure (after bend test)

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

    angle recess area (ARA)

    Measured: during the procedure (after bend test)

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

    iris-trabecular index of contact (ITIC)

    Measured: during the procedure (after bend test)

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

    Front R

    Measured: during the procedure (after bend test)

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

    Back R

    Measured: during the procedure (after bend test)

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

    Tilt

    Measured: during the procedure (after bend test)

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

    Lens thickness (LT)

    Measured: during the procedure (after bend test)

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

    Decent

    Measured: during the procedure (after bend test)

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

    LE-Dia

    Measured: during the procedure (after bend test)

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

    lens vault (LV)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: during the procedure (after bend test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start1 Nov 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163093
Sponsor's protocol ID
Angle closure glaucoma
Status last verified
Mar 2023
First submitted
7 Nov 2021
Last updated
7 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Angle-Closure Glaucoma, run by Chunyan Qiao_2021 at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chunyan Qiao, MD (86-176-1067-8637, chunyan_qiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visual acuity (VA) (time frame: baseline). The study lists 62 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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