RecruitingNot Applicable

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

China120 participantsStarted 2025-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tilt and Decentration

Timeframe: Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months

Trial details

NCT IDNCT07052825

SponsorJin Yang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Xuanqiao Lin

+8615088920668 1532483480@qq.com

View on ClinicalTrials.gov More High Myopia trials