RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form and comply with the study protocol and follow-up visits. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

CTR implantation

Phaco+IOL with CTR implantation

Locations (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China