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

NCT07052825 | Recruiting

• 2 other identifiers: HM CTR82171039
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia; Cataract

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tilt and Decentration

  measured by using anterior segment OCT

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

Secondary Outcomes (3)

• Anterior Capsular Contraction

  1 day, 1 week, 1 month, 3 months, and 6 months postoperatively

• visual acuity

  1 day, 1 week, 1 month, 3 months, and 6 months postoperatively

• Visual Quality

  1 day, 1 week, 1 month, 3 months, and 6 months postoperatively

Study Arms (2)

CTR implantation

EXPERIMENTAL

Phaco+IOL with CTR implantation

Procedure: CTR implantation

NCTR

NO INTERVENTION

Phaco+IOL without CTR implantation

Interventions

CTR implantation PROCEDURE

Phaco+IOL with CTR implantation

CTR implantation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of ocular trauma, surgery, or intraocular inflammation in either eye.
• Presence of other ocular diseases that may affect visual outcomes, such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity.
• Evidence of zonular weakness, pseudoexfoliation, or significant phacodonesis preoperatively.
• Severe dry eye or poor fixation that may interfere with postoperative imaging.
• Systemic diseases affecting visual function (e.g., uncontrolled diabetes, neurologic disorders).
• Participation in other clinical trials that may affect the study outcomes.

Sponsors & Collaborators

• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jin Yang

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xuanqiao Lin

CONTACT

+8615088920668; 1532483480@qq.com

Baoxian Zhuo

CONTACT

1532483480@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a self-controlled study. Each participant receives cataract surgery in both eyes, with one eye randomly assigned to CTR implantation and the fellow eye without CTR. The two eyes serve as within-subject comparators.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)