Factors Influencing Nocturnal Symptoms After Refractive Surgery.

Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.

By comparing the parameters of the two groups of patients with glare at night after refractive surgery and those without glare at night, the influence of preoperative related parameters on postoperative glare was analyzed.

Study Overview

• Status: Active, not recruiting
• Conditions: Refractive Surgery; Visual Quality
• Intervention / Treatment: Procedure: refractive surgery

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People undergoing refractive surgery.

Description

Inclusion criteria：

• Age ≥18 years old；
• Stable diopter (diopter change less than 0.5D in the past 2 years);
• Best corrected distance visual acuity (CDVA) of 1.0 or better；
• Anterior chamber depth (ACD) ≥2.8 mm;
• Corneal endothelial cell density (ECD) ≥ 2 000 cells/mm.

Exclusion criteria:

• History of ocular trauma or surgery;
• Suspected keratoconus;
• Previous history of other ocular diseases such as corneal inflammation or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataract, amblyopia, etc.;
• History of severe dry eye；
• Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; or severe mental disorders, such as anxiety and depression.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
glare group.; Patients subjectively complained about glare and Binoptometer examination showed poor visual quality in dark environments, and they were classified as the glare group.	Procedure: refractive surgery; refractive surgery
non-glare group; The patients did not complain of glare and the Binoptometer examination showed good visual quality in a dark environment, and they were classified as the non-glare group.	Procedure: refractive surgery; refractive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of diopter under bright and dark pupils.	Use OPDScan Ⅲ to measure the parameters of both eyes	Preoperative
Changes of diopter under bright and dark pupils.	Use OPDScan Ⅲ to measure the parameters of both eyes.	Day 7
Changes of diopter under bright and dark pupils.	Use OPDScan Ⅲ to measure the parameters of both eyes.	Month 1
Changes of diopter under bright and dark pupils.	Use OPDScan Ⅲ to measure the parameters of both eyes.	Month 3
Changes of diopter under bright and dark pupils.	Use OPDScan Ⅲ to measure the parameters of both eyes.	Month 6
objective visual quality.	Measurement of objective visual quality using Binopotometer.	Day 7
objective visual quality.	Measurement of objective visual quality using Binopotometer and NIDEK Automatic computerized optometry instrument（ARK-1s).	Month 1
objective visual quality.	Measurement of objective visual quality using Binopotometer.	Month 3
objective visual quality.	Measurement of objective visual quality using Binopotometer.	Month 6
subjective visual quality	Using visual quality questionnaire to evaluate patients' subjective visual quality.	Day 7
subjective visual quality	Using visual quality questionnaire to evaluate patients' subjective visual quality.	Month 1
subjective visual quality	Using visual quality questionnaire to evaluate patients' subjective visual quality.	Month 3
subjective visual quality	Using visual quality questionnaire to evaluate patients' subjective visual quality.	Month 6
ICL Vault	Measuring ICL vault with Pentacam	Day 7
ICL Vault	Measuring ICL vault with Pentacam	Month 1
ICL Vault	Measuring ICL vault with Pentacam	Month 3
ICL Vault	Measuring ICL vault with Pentacam	Month 6

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: glare; refractive surgery; pupil; visual quality; Aberrations
• Other Study ID Numbers: [2021] No. (113).

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