Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07052825

The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study

Led by Jin Yang · Updated on 2025-07-07

120

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Study Purpose: This prospective, self-controlled clinical study aims to evaluate the impact of capsular tension rings (CTR) on intraocular lens (IOL) stability in high myopia patients undergoing bilateral cataract surgery. Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, refraction, IOL positioning, and visual quality, will be compared between eyes to assess the effectiveness of CTR. Study Methods: Eligible participants (axial length ≥ 26.0 mm) will undergo femtosecond-assisted phacoemulsification with identical IOLs implanted in both eyes. One eye will be randomly assigned to receive a CTR. All surgeries will be performed by the same surgeon. Follow-up will be conducted at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Assessments will include UCVA, BCVA, refractive error, anterior segment OCT, IOL decentration and tilt, and visual quality (iTrace). Sample Size and Population: A total of 60 patients (120 eyes) will be enrolled. Inclusion criteria include age ≥ 18 years and bilateral cataracts with high myopia. Exclusion criteria include other ocular diseases, history of severe ocular trauma, or poor visual potential. Patients will be stratified by axial length into three groups: ≤28 mm, 28-30 mm, and \>30 mm. Study Procedure: After informed consent and baseline examinations (including ocular biometry and imaging), patients will undergo surgery and be followed at specified intervals. All data will be managed securely. Comparative analysis between CTR and non-CTR eyes will be performed to evaluate the effect of CTR on IOL stability and visual outcomes in highly myopic cataract patients.

CONDITIONS

Official Title

The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with bilateral age-related cataracts and planned for cataract surgery with IOL implantation in both eyes
  • High myopia in both eyes with axial length of 26.0 mm or more
  • Less than 1.0 mm difference in axial length between the two eyes
  • Willing and able to undergo surgery in both eyes within 1 to 2 weeks
  • Able to provide informed consent and follow study procedures including follow-up visits
Not Eligible

You will not qualify if you...

  • History of eye trauma, surgery, or inflammation in either eye
  • Presence of other eye diseases affecting vision such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity
  • Signs of zonular weakness, pseudoexfoliation, or significant lens instability before surgery
  • Severe dry eye or poor eye fixation interfering with imaging after surgery
  • Systemic diseases affecting vision like uncontrolled diabetes or neurological disorders
  • Participation in other clinical trials that could impact study results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

X

Xuanqiao Lin

CONTACT

B

Baoxian Zhuo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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