Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT06505434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia
Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Organization:
Study Overview
Official Title:
A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of appropriate IOLs, most cataract patients can achieve good distance vision after surgery. However, it should not be overlooked that the current global prevalence of myopia is over 28.3% and is expected to reach 49.8% by 2050, while the rate of high myopia will increase from the current 4.0% to 9.8%. The prevalence of cataracts is significantly higher in the highly myopic population than in the orthoptic population.
The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.
Objectives of the study
1. To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
2. To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.
The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.
Objectives of the study
1. To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
2. To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.
Detailed Description:
None
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?: