Factors Influencing Nocturnal Symptoms After Refractive Surgery.

Refractive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05658718
• Other study ID #: [2021] No. (113).
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Surgery
• Visual Quality

Intervention

Procedure:
• refractive surgery
refractive surgery

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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