Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05161520
Study type	Interventional
Source	Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact
Status	Recruiting
Phase	N/A
Start date	December 16, 2021
Completion date	December 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.