NCT05161520

Brief Summary

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.

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
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

December 2, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

December 2, 2021

Last Update Submit

April 17, 2023

Conditions

CataractHigh Myopia

Outcome Measures

Primary Outcomes (1)

  • IOL dencentration

    Measured by anterior segment OCT (CASIA2)

    3 months after surgery

Secondary Outcomes (8)

  • IOL dencentration

    Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery

  • IOL tilt

    Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery

  • Anterior capsule contraction

    Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery

  • Posterior capsule attachment with IOL

    1 week, 1 month, 3 months, 6 months, 1 year after surgery

  • Posterior capsular opacification

    1 week, 1 month, 3 months, 6 months, 1 year after surgery

  • +3 more secondary outcomes

Study Arms (2)

IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.

ACTIVE COMPARATOR
Procedure: phacoemulsification combined with IOL and CTR implantation

single IOL Patients will undergo phacoemulsification combined with IOL implantation.

PLACEBO COMPARATOR
Procedure: phacoemulsification combined with IOL implantation

Interventions

phacoemulsification combined with IOL and CTR implantationPROCEDURE

Device: CTR (276001G； OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL is implanted.

IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.
phacoemulsification combined with IOL implantationPROCEDURE

Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.

single IOL Patients will undergo phacoemulsification combined with IOL implantation.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old;
  • axis length≥26mm;
  • Visually significant cataract;
  • The patient is willing and able to complete all necessary follow-ups and examinations.

You may not qualify if:

  • Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.;
  • Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
  • History of intraocular surgery;
  • Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
  • Any condition that the study physician considers to be an impediment to the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • Lin H, Zhang J, Jin A, Zhang Y, Zhang Y, Jin L, Xu Y, Xie X, Qiu X, Dai B, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Power Calculation in Highly Myopic Eyes: Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):373-381. doi: 10.1001/jamaophthalmol.2025.0110.

    PMID: 40111331DERIVED

  • Lin H, Zhang J, Zhang Y, Jin A, Zhang Y, Jin L, Xu Y, Xie X, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Decentration and Tilt in Highly Myopic Eyes: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Aug 1;142(8):708-715. doi: 10.1001/jamaophthalmol.2024.2215.

    PMID: 38935400DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 17, 2021

Study Start

December 16, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

CN(1)