Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
Study NCT ID:
NCT05161520
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Capsular Tension Ring Implantation on Intraocular Lens Position
Sponsor:
Xuhua Tan
Organization:
Study Overview
Official Title:
Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: