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

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

This test will see if placing a capsular tension ring in one eye during cataract surgery helps the artificial lens stay centered and gives better vision for people with high myopia, by comparing the treated eye to the other eye without the ring.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07052825 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with bilateral age-related cataracts and high myopia (axial length ≥ 26.0 mm) who can have bilateral femtosecond-assisted cataract surgery within a short interval, have minimal interocular axial length difference, and have no other ocular comorbidities or zonular weakness.

Not a fit: Patients with prior ocular trauma or surgery, preexisting zonular weakness or pseudoexfoliation, significant retinal or corneal disease, large interocular axial length differences, or inability to complete bilateral surgery and follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, CTR implantation could reduce intraocular lens tilt and decentration in highly myopic eyes, improving visual quality and refractive predictability after cataract surgery.

How similar studies have performed: Capsular tension rings are established to improve IOL stability in eyes with zonular compromise and some reports show reduced tilt and decentration, but controlled bilateral data specifically in highly myopic patients are limited.

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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Xuanqiao Lin

Conditions High Myopia; Cataract; Capsular Tension Ring（CTR）, High Myopia, Intraocular lens, Tilt, Decentration, Visual Quality