Actively Recruiting
The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
Led by Jin Yang · Updated on 2025-07-07
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of capsular tension rings (CTR) on the stability of intraocular lenses (IOL) in patients with high myopia undergoing cataract surgery in both eyes. This prospective, self-controlled clinical study involves patients with axial length of 26.0 mm or greater who have bilateral cataracts. The aim is to compare visual acuity, refraction, IOL positioning, and visual quality between eyes implanted with CTR and those without, to understand the effect of CTR on postoperative outcomes. Participants will receive femtosecond-assisted phacoemulsification and identical IOLs implanted in both eyes, with one eye randomly assigned to receive a CTR. All surgeries are performed by the same surgeon. Patients will be followed up at 1 day, 1 week, 1 month, 3 months, and 6 months after surgery. Assessments include uncorrected and best corrected visual acuity, refractive error, intraocular pressure, anterior segment morphology via OCT, IOL decentration and tilt, and visual quality measured by iTrace. During the study, participants will undergo baseline examinations including ocular biometry and imaging before surgery. Follow-up visits will monitor visual function and IOL positioning at specific timepoints up to 6 months. Data will be securely managed, and the final analysis will compare the visual outcomes and IOL stability between eyes with and without CTR. The primary outcome measure is IOL tilt and decentration, with secondary measures including anterior capsular contraction, visual acuity, and visual quality.
CONDITIONS
Brief Title
The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with bilateral age-related cataracts and scheduled for cataract surgery with intraocular lens implantation in both eyes
- High myopia in both eyes, defined as axial length 26.0 mm or longer
- No significant difference in axial length between the two eyes (less than 1.0 mm difference)
- Willing and able to undergo cataract surgery in both eyes within 1 to 2 weeks
- Able to provide informed consent and comply with study and follow-up visits
You will not qualify if you...
- History of eye trauma, surgery, or intraocular inflammation in either eye
- Presence of other eye diseases affecting vision such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity
- Signs of zonular weakness, pseudoexfoliation, or significant lens instability before surgery
- Severe dry eye or poor eye fixation that could interfere with imaging after surgery
- Systemic diseases affecting vision like uncontrolled diabetes or neurological disorders
- Participation in other clinical trials that might affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 weeks
Participants undergo femtosecond-assisted phacoemulsification cataract surgery in both eyes, with one eye receiving a capsular tension ring (CTR) and the other eye not receiving a CTR, followed by immediate post-operative care.
1 surgery visit
Duration - 6 months
Participants attend multiple follow-up visits to assess visual acuity, refraction, intraocular pressure, anterior segment morphology, intraocular lens stability, and visual quality.
Visits at 1 day, 1 week, 1 month, 3 months, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
X
Xuanqiao Lin
B
Baoxian Zhuo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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