A Comparative Study of the Results of Dynamic and OPD Static Measurement of Pupil Diameter Before and After Cataract Surgery by Pupil Detectors

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 a suitable IOL, most cataract patients can achieve good distance vision after surgery. Studies have shown differences in pupil diameter and sensitivity in patients with different refractive states, with correlations to accommodation status as well as refractive error. The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL.

Among the various instruments used for preoperative cataract biological measurements, the light source is mostly a fixed parameter, and the static pupil diameter measurement by fixed illumination light source detection as an evaluation method is relatively rough. In this study, we are going to simulate different illumination states in daily life and set up two kinds of measurement instruments, namely, OPD and binocular pupil detector, so as to obtain more realistic research results and to explore the following: 1. The static and dynamic measurement of pupil diameter by people of different refractive states in different periods of preoperative and postoperative period. 2. Whether there is a difference between the static and dynamic pupil measurement results, 2. the change of pupil size under the stimulation of different light sources, and to compare the difference between the two detection methods, to provide objective pupil indexes for the more scientific selection of functional IOLs, to provide a basis for the selection of more accurate pupil measurement methods, to accurately screen the population of the use of functional IOLs, and to improve the patient's satisfaction after the operation.

Purpose of the study To simulate the difference between the preoperative and postoperative pupil diameters of cataract patients measured by static and dynamic methods under daily illumination, to select a more accurate pupil measurement method, and to make corrections for the evaluation of preoperative biometric indexes.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Procedure: cataract surgery

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Sixty eyes of patients who were treated with lens ultrasonic emulsification combined with IOL implantation in our hospital were selected. According to the preoperative refractive status, they were divided into orthokeratology group (-0.5D~+0.5D), myopia group less than -0.5D, hyperopia group more than +0.5D, 20 eyes in each group.

Description

Inclusion Criteria:

(1) diagnosed with cataract; (2) treated with lens ultrasonic emulsification combined with monofocal IOL implantation in our hospital; (3) agreed to participate and cooperate with this study.

Exclusion Criteria:

(1) acute eye disease symptoms, such as eye redness, eye pain, increased ocular secretions, etc.; (2) other eye diseases that seriously affect visual function in both eyes, such as amblyopia, high myopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment, etc.; (3) intra-operative or post-operative complications in cataract surgery; combined with other ophthalmic surgeries; and any other ophthalmic surgery for both eyes in the follow-up period; the presence of any other ophthalmic surgery in both eyes in the follow-up period. (4) Inability to understand the informed consent form and inability to communicate.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Orthokeratology group; -0.5D~+0.0D	Procedure: cataract surgery; Phaco+IOL implention
myopia group; SE lens less than -0.5D	Procedure: cataract surgery; Phaco+IOL implention
hyperopia group; SE more than +0.5D	Procedure: cataract surgery; Phaco+IOL implention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupil size	pupil size before and after cataract surgery	1 week, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: cataract; pupil size
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: QX-2023-A-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No