Factors Influencing Nocturnal Symptoms After Refractive Surgery.

• Sponsor: Second Affiliated Hospital of Nanchang University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05658718
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 28.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Surgery; Visual Quality	Procedure: refractive surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Changes of diopter under bright and dark pupils. [Preoperative]

   Use OPDScan Ⅲ to measure the parameters of both eyes

2. Changes of diopter under bright and dark pupils. [Day 7]

   Use OPDScan Ⅲ to measure the parameters of both eyes.

3. Changes of diopter under bright and dark pupils. [Month 1]

   Use OPDScan Ⅲ to measure the parameters of both eyes.

4. Changes of diopter under bright and dark pupils. [Month 3]

   Use OPDScan Ⅲ to measure the parameters of both eyes.

5. Changes of diopter under bright and dark pupils. [Month 6]

   Use OPDScan Ⅲ to measure the parameters of both eyes.

6. objective visual quality. [Day 7]

   Measurement of objective visual quality using Binopotometer.

7. objective visual quality. [Month 1]

   Measurement of objective visual quality using Binopotometer and NIDEK Automatic computerized optometry instrument（ARK-1s).

8. objective visual quality. [Month 3]

   Measurement of objective visual quality using Binopotometer.

9. objective visual quality. [Month 6]

   Measurement of objective visual quality using Binopotometer.

10. subjective visual quality [Day 7]

    Using visual quality questionnaire to evaluate patients' subjective visual quality.

11. subjective visual quality [Month 1]

    Using visual quality questionnaire to evaluate patients' subjective visual quality.

12. subjective visual quality [Month 3]

    Using visual quality questionnaire to evaluate patients' subjective visual quality.

13. subjective visual quality [Month 6]

    Using visual quality questionnaire to evaluate patients' subjective visual quality.

14. ICL Vault [Day 7]

    Measuring ICL vault with Pentacam

15. ICL Vault [Month 1]

    Measuring ICL vault with Pentacam

16. ICL Vault [Month 3]

    Measuring ICL vault with Pentacam

17. ICL Vault [Month 6]

    Measuring ICL vault with Pentacam

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330000

Sponsors and Collaborators

• Second Affiliated Hospital of Nanchang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yifeng Yu, Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University
• ClinicalTrials.gov Identifier: NCT05658718
• Other Study ID Numbers: [2021] No. (113).
• First Posted: Dec 21, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yifeng Yu, Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University: refractive surgery; glare; pupil; visual quality; Aberrations

Study Results

No Results Posted as of Dec 21, 2022