NCT05542290

Brief Summary

Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

September 3, 2022

Last Update Submit

March 6, 2023

Conditions

GlaucomaAngle-Closure

Keywords

angle closurezonular laxityzonular dialysislens subluxationcapsular tension ringefficacysafety

Outcome Measures

Primary Outcomes (113)

  • Spherical equivalent

    Sphere +1/2 cylinder obtained from subjective refraction

    baseline

  • Spherical equivalent

    Sphere +1/2 cylinder obtained from subjective refraction

    1 month after the surgery

  • Spherical equivalent

    Sphere +1/2 cylinder obtained from subjective refraction

    3 months after the surgery

  • Spherical equivalent

    Sphere +1/2 cylinder obtained from subjective refraction

    6 months after the surgery

  • Spherical equivalent

    Sphere +1/2 cylinder obtained from subjective refraction

    12 months after the surgery

  • Area of anterior capsulorhexis

    Area of anterior capsulorhexis measured using slit-lamp photography

    1 week after the surgery

  • Area of anterior capsulorhexis

    Area of anterior capsulorhexis measured using slit-lamp photography

    1 month after the surgery

  • Area of anterior capsulorhexis

    Area of anterior capsulorhexis measured using slit-lamp photography

    3 months after the surgery

  • Area of anterior capsulorhexis

    Area of anterior capsulorhexis measured using slit-lamp photography

    6 months after the surgery

  • Area of anterior capsulorhexis

    Area of anterior capsulorhexis measured using slit-lamp photography

    12 months after the surgery

  • Assessment of posterior capsular opacification

    Assessment of posterior capsular opacification using slit-lamp photography

    1 week after the surgery

  • Assessment of posterior capsular opacification

    Assessment of posterior capsular opacification using slit-lamp photography

    1 month after the surgery

  • Assessment of posterior capsular opacification

    Assessment of posterior capsular opacification using slit-lamp photography

    3 months after the surgery

  • Assessment of posterior capsular opacification

    Assessment of posterior capsular opacification using slit-lamp photography

    6 months after the surgery

  • Assessment of posterior capsular opacification

    Assessment of posterior capsular opacification using slit-lamp photography

    12 months after the surgery

  • The extent of iris-trabecular contact

    The extent of iris-trabecular contact assessed by gonioscopy

    baseline

  • The extent of iris-trabecular contact

    The extent of iris-trabecular contact assessed by gonioscopy

    1 month after the surgery

  • The extent of iris-trabecular contact

    The extent of iris-trabecular contact assessed by gonioscopy

    3 months after the surgery

  • The extent of iris-trabecular contact

    The extent of iris-trabecular contact assessed by gonioscopy

    6 months after the surgery

  • The extent of iris-trabecular contact

    The extent of iris-trabecular contact assessed by gonioscopy

    12 months after the surgery

  • The extent of peripheral anterior synechia

    The extent of peripheral anterior synechia assessed by gonioscopy

    baseline

  • The extent of peripheral anterior synechia

    The extent of peripheral anterior synechia assessed by gonioscopy

    1 month after the surgery

  • The extent of peripheral anterior synechia

    The extent of peripheral anterior synechia assessed by gonioscopy

    3 months after the surgery

  • The extent of peripheral anterior synechia

    The extent of peripheral anterior synechia assessed by gonioscopy

    6 months after the surgery

  • The extent of peripheral anterior synechia

    The extent of peripheral anterior synechia assessed by gonioscopy

    12 months after the surgery

  • Corneal thickness

    Corneal thickness obtained by IOL Master 700

    baseline

  • Central anterior chamber depth

    Central anterior chamber depth obtained by IOL Master 700

    baseline

  • Lens thickness

    Lens thickness obtained by IOL Master 700

    baseline

  • Axial Length

    Axial Length obtained by IOL Master 700

    baseline

  • Refractive prediction error

    Refractive prediction error obtained by IOL Master 700

    baseline

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    baseline

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Anterior chamber depth

    Anterior chamber depth obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    baseline

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Angle opening distance

    Angle opening distance obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    baseline

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Trabecular-iris space area

    Trabecular-iris space area obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    baseline

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Trabecular-iris angle

    Trabecular-iris angle obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    baseline

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Anterior chamber width

    Anterior chamber width obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    baseline

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Iris thickness

    Iris thickness obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    baseline

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Iris cross-sectional area

    Iris cross-sectional area obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    baseline

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Iris curvature

    Iris curvature obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    baseline

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Lens thickness

    Lens thickness obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    baseline

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    1 week after the surgery

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    1 month after the surgery

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    3 months after the surgery

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    6 months after the surgery

  • Lens vault

    Lens vault obtained by anterior segment optical coherence tomography

    12 months after the surgery

  • The distance between intraocular lens and the posterior capsular

    The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography

    1 week after the surgery

  • The distance between intraocular lens and the posterior capsular

    The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography

    1 month after the surgery

  • The distance between intraocular lens and the posterior capsular

    The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography

    3 months after the surgery

  • The distance between intraocular lens and the posterior capsular

    The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography

    6 months after the surgery

  • The distance between intraocular lens and the posterior capsular

    The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography

    12 months after the surgery

  • Intraocular lens inclination angle

    Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

    1 week after the surgery

  • Intraocular lens inclination angle

    Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

    1 month after the surgery

  • Intraocular lens inclination angle

    Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

    3 months after the surgery

  • Intraocular lens inclination angle

    Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

    6 months after the surgery

  • Intraocular lens inclination angle

    Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

    12 months after the surgery

  • Effective intraocular lens position

    Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography

    1 week after the surgery

  • Effective intraocular lens position

    Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography

    1 month after the surgery

  • Effective intraocular lens position

    Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography

    3 months after the surgery

  • Effective intraocular lens position

    Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography

    6 months after the surgery

  • Effective intraocular lens position

    Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography

    12 months after the surgery

  • The distance between ciliary body and the equator of lens at 3 o'clock position

    The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy

    baseline

  • The distance between ciliary body and the equator of lens at 6 o'clock position

    The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy

    baseline

  • The distance between ciliary body and the equator of lens at 9 o'clock position

    The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy

    baseline

  • The distance between ciliary body and the equator of lens at 12 o'clock position

    The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy

    baseline

  • Incidence of complications

    Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.

    1 month after the surgery

  • Incidence of complications

    Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.

    3 months after the surgery

  • Incidence of complications

    Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.

    6 months after the surgery

  • Incidence of complications

    Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.

    12 months after the surgery

Secondary Outcomes (28)

  • Presenting visual acuity

    baseline

  • Presenting visual acuity

    1 day after the surgery

  • Presenting visual acuity

    1 week after the surgery

  • Presenting visual acuity

    1 month after the surgery

  • Presenting visual acuity

    3 months after the surgery

  • +23 more secondary outcomes

Study Arms (2)

With capsular tension ring implantation

EXPERIMENTAL

We performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis.

Procedure: Capsular tension ring implantation

Without capsular tension ring implantation

OTHER

We performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis.

Procedure: No capsular tension ring implantation

Interventions

Capsular tension ring implantationPROCEDURE

Capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.

With capsular tension ring implantation
No capsular tension ring implantationPROCEDURE

No capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.

Without capsular tension ring implantation

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 45-79 years old
  • Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
  • Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)

You may not qualify if:

  • Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
  • Past history of laser peripheral iridotomy or iridoplasty
  • Past history of ocular trauma or signs referring to ocular trauma
  • Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
  • Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
  • Other secondary angle closure glaucoma, including neovascular glaucoma, iritis related secondary glaucoma and so on
  • Visualization of capsular equator and infolding of peripheral capsule \> 4 clocks during the surgery
  • Anterior or posterior capsule rupture during the surgery which makes it impossible for CTR implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

GlaucomaLens Subluxation

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Central Study Contacts

Chunyan Qiao, M.D.

CONTACT

86-17610678637chunyan_qiao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist, Professor, M.D.

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 15, 2022

Study Start

March 1, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)