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Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis

Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05542290
Enrollment
156
Registered
2022-09-15
Start date
2023-03-01
Completion date
2025-10-01
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angle-Closure, Glaucoma

Keywords

angle closure, zonular laxity, zonular dialysis, lens subluxation, capsular tension ring, efficacy, safety

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.

Detailed description

Patients with PACD who are scheduled to have phacoemulsification and IOL implantation combined with goniosynechialysis are recruited. All recruited patients attended comprehensive eye examinations and interviews. Past history of ocular and systemic diseases, family and personal history, history of ocular trauma and surgery were interviewed. And the patients underwent ophthalmic examinations including visual acuity tests (presenting visual acuity \[PVA\] and best-corrected visual acuity \[BCVA\]), subjective refraction, intraocular pressure (IOP) measurements, slit-lamp examination, fundus photography, gonioscopy, ocular biometry using IOL Master 700, ultrasound biomicroscopy, anterior segment optical coherence tomography (ASOCT) imaging. All patients provide informed consent for inclusion in the study. All surgery procedures were performed by the same surgeons (CYQ) using the same standard operation procedure. All patients use the same type of foldable IOL calculated using SRK/T formula. During the surgery, patients with wrinkling of the anterior capsule (multiple sinusoidal folds were formed) during continuous curvilineal capsulorhexis (CCC) at the needle or forceps tip but without infolding of peripheral capsule or visualisation of the capsular equator during the cortical or nuclear removal, or, wrinkling of the anterior capsule during CCC with infolding of peripheral capsule and visualisation of the capsular equator ≤ 4 clocks of range during the cortical or nuclear removal, were finally included in the study and randomly assigned (using a random-number table generated by SAS) with equal probability to either CTR group (with CTR implantation during the surgery) and control group (without CTR implantation during the surgery). All patients included in the CTR group use the same type of CTR. The investigators recorded the complications during the surgery including vitreous prolapse, hyphema, vitreous hemorrhage, damage of iris and lens capsule, et al. Postoperatively, all patients received similar routine medication comprising topical prednisolone acetate (six times a day for 1 week and tapered down by 1 time every week), topical levofloxacin hydrochloride (four times a day for 1 month), and Tobramycin and Dexamethasone Eye Ointment (1 time every night for 1 month). Postoperative examinations were performed at 1 day, 1 week, 1 months, 3 months, 6 months and 12 months. During the follow-up visits, a complete ophthalmic examination was performed including PVA, BCVA, subjective refraction, non-contact IOP measurement, slit-lamp examination, slit-lamp photography after pupil dilation, ASOCT, gonioscopy, and fundus imaging.

Interventions

PROCEDURECapsular tension ring implantation

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

PROCEDURENo capsular tension ring implantation

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

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* 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) * The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The distance between ciliary body and the equator of lens at 12 o'clock positionbaselineThe distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Effective intraocular lens position1 week after the surgeryEffective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Incidence of complications1 month after the surgeryIncidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
The distance between ciliary body and the equator of lens at 9 o'clock positionbaselineThe distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 3 o'clock positionbaselineThe distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 6 o'clock positionbaselineThe distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
The extent of iris-trabecular contactbaselineThe extent of iris-trabecular contact assessed by gonioscopy
Spherical equivalentbaselineSphere +1/2 cylinder obtained from subjective refraction
Area of anterior capsulorhexis1 week after the surgeryArea of anterior capsulorhexis measured using slit-lamp photography
Assessment of posterior capsular opacification1 week after the surgeryAssessment of posterior capsular opacification using slit-lamp photography
The extent of peripheral anterior synechiabaselineThe extent of peripheral anterior synechia assessed by gonioscopy
Corneal thicknessbaselineCorneal thickness obtained by IOL Master 700
Central anterior chamber depthbaselineCentral anterior chamber depth obtained by IOL Master 700
Lens thicknessbaselineLens thickness obtained by IOL Master 700
Axial LengthbaselineAxial Length obtained by IOL Master 700
Refractive prediction errorbaselineRefractive prediction error obtained by IOL Master 700
Anterior chamber depthbaselineAnterior chamber depth obtained by anterior segment optical coherence tomography
Angle opening distancebaselineAngle opening distance obtained by anterior segment optical coherence tomography
Trabecular-iris space areabaselineTrabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris anglebaselineTrabecular-iris angle obtained by anterior segment optical coherence tomography
Anterior chamber widthbaselineAnterior chamber width obtained by anterior segment optical coherence tomography
Iris thicknessbaselineIris thickness obtained by anterior segment optical coherence tomography
Iris cross-sectional areabaselineIris cross-sectional area obtained by anterior segment optical coherence tomography
Iris curvaturebaselineIris curvature obtained by anterior segment optical coherence tomography
Lens vaultbaselineLens vault obtained by anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular1 week after the surgeryThe distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle1 week after the surgeryIntraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography

Secondary

MeasureTime frameDescription
Best corrected visual acuitybaselineVisual acuity with refractive correction
Intraocular pressurebaselineIntraocular pressure obtained by non-contact tonometer
Number of anti-glaucoma medications1 week after the surgeryNumber of anti-glaucoma medications
Vertical cup-to-disc ratiobaselineVertical cup-to-disc ratio evaluated by fundus photography
Presenting visual acuitybaselinePresenting visual acuity with or without glasses

Countries

China

Contacts

Primary ContactChunyan Qiao, M.D.
chunyan_qiao@163.com86-17610678637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026