Cataract Clinical Trial
Official title:
Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
Verified date | April 2023 |
Source | Zhongshan Ophthalmic Center, Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.
Status | Recruiting |
Enrollment | 186 |
Est. completion date | December 2024 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. > 18 years old; 2. axis length=26mm; 3. Visually significant cataract; 4. The patient is willing and able to complete all necessary follow-ups and examinations. Exclusion Criteria: 1. Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.; 2. Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; 3. History of intraocular surgery; 4. Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.; 5. Any condition that the study physician considers to be an impediment to the clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Xuhua Tan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOL dencentration | Measured by anterior segment OCT (CASIA2) | 3 months after surgery | |
Secondary | IOL dencentration | Measured by anterior segment OCT (CASIA2) | Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery | |
Secondary | IOL tilt | Measured by anterior segment OCT (CASIA2) | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | Anterior capsule contraction | Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software. | Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | Posterior capsule attachment with IOL | Measured by anterior segment OCT (CASIA2) and analyzed by Image J software. | 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | Posterior capsular opacification | Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software. | 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | BCVA | BCVA is evaluated with ETDRS visual acuity chart. | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | Optical quality | Measured by OPD-SCAN III. | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery | |
Secondary | Visual function | Measured by visual function assessment questionnaires. | 3 months, 6 months, 1 year after surgery |
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