Evaluation of Toric Intraocular Lens(IOL) Combined With Capsular Tension Ring(CTR) in Patients With Cataract Combined With High Myopia

NCT06571773 | Active Not Recruiting

• 1 other identifier: SHISY-LYZX-217
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the postoperative visual quality and IOL stability in patients with cataracts and high myopia who have undergone surgery using astigmatism-correcting IOLs in conjunction with tension rings.It is a non-randomised retroprospective cohort study. Patients with high axial myopia (AL ≥ 26 mm) who underwent cataract phacoemulsification combined with toric IOL(Acrysof SN6ATY IQ toric IOL, Alcon, Alcon Laboratories, Fort Worth, Texas, USA) implantation from October 2020 to September 2023 at the Shanghai Tenth People's Hospital are selected. According to the usage of CTR, all patients will be divided into CTR group and control group, with a minimum follow-up of 3 months.Each patient underwent a comprehensive preoperative examination and ophthalmological examinations at the outpatient clinic 1 day, 1 week, 1 month, and 3 months postoperatively.Statistical analysis will be conducted using SPSS 26.0 statistical software.

Conditions

Cataract; Astigmatism; Intraocular Lens Rotation

Outcome Measures

Primary Outcomes (1)

• Postoperative IOL rotation degree

  The surgeon, using the same slit lamp microscope and a narrow band of light, measured the IOL axial position after the patients' pupils were fully dilated with compound tropicamide eye drops

  3 months

Study Arms (2)

CTR group

This group include the patients with the usage of CTR

Procedure: intraoperative implantation of Capsular Tension Ring

control group

This group include the patients without the usage of CTR

Procedure: none intraoperative implantation of CTR

Interventions

intraoperative implantation of Capsular Tension Ring PROCEDURE

The Capsular Tension Ring(ACPi-11; Bausch + Lomb, Rochester, New York, USA) is a device made of PMMA with blunt-tipped eyelets at its ends. It can be inserted at any point during cataract surgery, following the creation of a strong anterior capsulotomy via capsulorhexis

CTR group

none intraoperative implantation of CTR PROCEDURE

the surgeon did a surgery without the intraoperative implantation of CTR

control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cataract ultrasonic emulsification aspiration with one-stage implantation of astigmatic IOL at the Shanghai Tenth People's Hospital from October 2020 to September 2023

You may qualify if:

• Cataract ultrasonic emulsification aspiration with one-stage implantation of astigmatic IOL at the Shanghai Tenth People's Hospital from October 2020 to September 2023;
• Ocular axial length ≥26.00mm;
• Completion of outpatient follow up for more than 3 months.

You may not qualify if:

• irregular corneal astigmatism, iris abnormalities, and pupil distortion;
• history of previous corneal or intraocular surgery;
• previous ocular diseases such as uveitis, retinopathy, macular degeneration, glaucoma, and keratoconus;
• postoperative posterior capsule rupture, and suspensory ligament dissociation of greater than 1 quadrant;
• corneal endothelial cell counts of less than 2000 cells/mm2.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Yili Sun

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: January 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: August 28, 2025

Record last verified: 2024-08

Locations

CN (1)