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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Eye and ENT hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xuanqiao Lin
1532483480@qq.com
+8615088920668
Backup
Baoxian Zhuo
1532483480@qq.com
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 120
Treatments
Experimental: CTR implantation
Phaco+IOL with CTR implantation
No_intervention: NCTR
Phaco+IOL without CTR implantation
Sponsors
Leads: Jin Yang

This content was sourced from clinicaltrials.gov