Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
NCT Number: NCT05161520
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510060, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 3 months after surgery
Measured by anterior segment OCT (CASIA2)
Time frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year, 3 year after surgery
Measured by anterior segment OCT (CASIA2)
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Measured by anterior segment OCT (CASIA2)
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
BCVA is evaluated with ETDRS visual acuity chart.
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Measured by OPD-SCAN III.
Time frame: 3 months, 6 months, 1 year, 3 year after surgery
Measured by visual function assessment questionnaires.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
IOL dislocation, retinal detachment, etc.
Time frame: Up to 3 years
Time from cataract surgery to Nd:YAG laser posterior capsulotomy. Participants without capsulotomy will be censored at their last follow-up visit. Cumulative probability of capsulotomy over time will be estimated using Kaplan-Meier survival analysis.
This study is active but is not currently recruiting participants.
Notify MeXuhua Tan
Other
Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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