NCT07052825 The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
| NCT ID | NCT07052825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jin Yang |
| Condition | High Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Jin Yang
STUDY CHAIR
Fudan University
Frequently Asked Questions
Who can join the NCT07052825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying High Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052825 currently recruiting?
Yes, NCT07052825 is actively recruiting participants. Contact the research team at 1532483480@qq.com for enrollment information.
Where is the NCT07052825 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07052825 clinical trial?
NCT07052825 is sponsored by Jin Yang. The principal investigator is Jin Yang at Fudan University. The trial plans to enroll 120 participants.