Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

Xuhua Tan186 enrolled

Overview

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.

Exact positioning and alignment of the IOL with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. A certain degree of IOL tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. However, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the IOL position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. Thus, how to improve the long-term stability of IOL position in high myopic cataract patients is an urgent issue to be addressed. Previous studies have shown that CTR implantation during cataract surgery can increase the IOL stability in patients with normal axial length; however, its impact on IOL position of cataract patients with high myopia remains unclear. In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length: (1)26mm≤AL\<28mm (2)28mm≤AL\<30mm (3)AL≥30mm We are going to recruit 186 patients in total, with 62 patients in each layer. Patients on each layer will be randomly divided into experimental group (CTR implantation) and control group (only IOL implantation). If both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis. All included patients will be followed up at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. Visual acuity, IOL tilt, IOL decentration, posterior capsule attachment with IOL, anterior capsule contraction, posterior capsular opacification, and visual quality will be measured and compared between the experimental group and the control group at different timepoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

186

Conditions

Cataract High Myopia

Interventions

phacoemulsification combined with IOL and CTR implantationPROCEDURE

Device: CTR (276001G； OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL is implanted.

phacoemulsification combined with IOL implantationPROCEDURE

Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

IOL dencentration

Measured by anterior segment OCT (CASIA2)

Time frame: 3 months after surgery

Secondary Outcomes

IOL dencentration

Measured by anterior segment OCT (CASIA2)

Time frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery

IOL tilt

Measured by anterior segment OCT (CASIA2)

Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery

Anterior capsule contraction

Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.

Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery

Posterior capsule attachment with IOL

Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year after surgery

Posterior capsular opacification

Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year after surgery

BCVA

BCVA is evaluated with ETDRS visual acuity chart.

Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery

Optical quality

Measured by OPD-SCAN III.

Data from ClinicalTrials.gov

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