Factors Influencing Nocturnal Symptoms After Refractive Surgery.
Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 7, 2023
September 1, 2023
2.1 years
November 20, 2022
September 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
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
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
People undergoing refractive surgery.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Related Publications (1)
Xiong J, Xu J, Zhou M, Liu J, Wang Q, Yin X, Deng Y, Luo X, Wang N, Gui F, Yu K, Liu J, Zhu Z, Cheng C, Yu Y. Mesopic pupil indices as potential risk factors for glare disability after intraocular implantable collamer lens implantation: prospective study. J Cataract Refract Surg. 2024 Jun 1;50(6):565-571. doi: 10.1097/j.jcrs.0000000000001420.
PMID: 38350161DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University
Study Record Dates
First Submitted
November 20, 2022
First Posted
December 21, 2022
Study Start
November 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
September 7, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share