Capsular tension ring to improve intraocular lens stability in people with high myopia and cataracts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, self-controlled study enrolls adults with bilateral high myopia (axial length ≥ 26.0 mm) who will undergo femtosecond-assisted phacoemulsification with the same model intraocular lens implanted in both eyes. One eye will be randomized to receive a capsular tension ring (CTR) while the fellow eye serves as the control, and all surgeries will be performed by the same surgeon. Participants will be followed at 1 day, 1 week, 1 month, 3 months, and 6 months with measurements of UCVA, BCVA, refractive error, anterior segment OCT, IOL decentration and tilt, and objective visual quality (iTrace). Outcomes between eyes will be compared to determine whether CTR implantation reduces IOL tilt or decentration and improves postoperative visual quality in highly myopic eyes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosed with bilateral age-related cataracts and scheduled for phacoemulsification with IOL implantation in both eyes.
3. High myopia in both eyes, defined as axial length (AL) ≥ 26.0 mm.
4. No significant difference in axial length between the two eyes (e.g., interocular AL difference \< 1.0 mm).
5. Willingness and ability to undergo bilateral surgery within a short interval (e.g., within 1-2 weeks).
6. Able to provide informed consent and comply with the study protocol and follow-up visits.

Exclusion Criteria:

1. History of ocular trauma, surgery, or intraocular inflammation in either eye.
2. Presence of other ocular diseases that may affect visual outcomes, such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity.
3. Evidence of zonular weakness, pseudoexfoliation, or significant phacodonesis preoperatively.
4. Severe dry eye or poor fixation that may interfere with postoperative imaging.
5. Systemic diseases affecting visual function (e.g., uncontrolled diabetes, neurologic disorders).
6. Participation in other clinical trials that may affect the study outcomes.

Where it's running

• Eye and ENT hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xuanqiao Lin
• Email: 1532483480@qq.com
• Phone: +8615088920668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.