Refractive SurgeryNCT05658718
Factors Influencing Nocturnal Symptoms After Refractive Surgery.
An observational study of Refractive Surgery and Visual Quality, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery, Visual Quality
- What is being tested?
- refractive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People undergoing refractive surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: 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.
- Conditions
- Refractive Surgery, Visual Quality
- Being tested
- refractive surgery
- Keywords
- refractive surgery, glare, pupil, visual quality, Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refractive surgeryProcedure or surgery
refractive surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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. Receives: Procedure: refractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of diopter under bright and dark pupils.
Use OPDScan Ⅲ to measure the parameters of both eyes
Measured: Preoperative
Changes of diopter under bright and dark pupils.
Use OPDScan Ⅲ to measure the parameters of both eyes.
Measured: Day 7
Changes of diopter under bright and dark pupils.
Use OPDScan Ⅲ to measure the parameters of both eyes.
Measured: Month 1
Changes of diopter under bright and dark pupils.
Use OPDScan Ⅲ to measure the parameters of both eyes.
Measured: Month 3
Changes of diopter under bright and dark pupils.
Use OPDScan Ⅲ to measure the parameters of both eyes.
Measured: Month 6
objective visual quality.
Measurement of objective visual quality using Binopotometer.
Measured: Day 7
objective visual quality.
Measurement of objective visual quality using Binopotometer and NIDEK Automatic computerized optometry instrument（ARK-1s).
Measured: Month 1
objective visual quality.
Measurement of objective visual quality using Binopotometer.
Measured: Month 3
objective visual quality.
Measurement of objective visual quality using Binopotometer.
Measured: Month 6
subjective visual quality
Using visual quality questionnaire to evaluate patients' subjective visual quality.
Measured: Day 7
subjective visual quality
Using visual quality questionnaire to evaluate patients' subjective visual quality.
Measured: Month 1
subjective visual quality
Using visual quality questionnaire to evaluate patients' subjective visual quality.
Measured: Month 3
subjective visual quality
Using visual quality questionnaire to evaluate patients' subjective visual quality.
Measured: Month 6
ICL Vault
Measuring ICL vault with Pentacam
Measured: Day 7
ICL Vault
Measuring ICL vault with Pentacam
Measured: Month 1
ICL Vault
Measuring ICL vault with Pentacam
Measured: Month 3
ICL Vault
Measuring ICL vault with Pentacam
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658718
- Sponsor's protocol ID
- [2021] No. (113).
- Status last verified
- Sep 2023
- First submitted
- 20 Nov 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38350161
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.
- ClinicalTrials.gov ID
- NCT05658718
- Acronym / sponsor ID
- [2021] No. (113).
- Conditions
- Refractive Surgery, Visual Quality
- Keywords
- refractive surgery, glare, pupil, visual quality, Aberrations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glare group. | – | Procedure: refractive surgeryPatients 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 | – | Procedure: refractive surgeryThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People undergoing refractive surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| refractive surgeryrefractive surgery | Procedure or surgery | glare group., non-glare group |
Primary outcome
Changes of diopter under bright and dark pupils.
Time frame: Preoperative
Use OPDScan Ⅲ to measure the parameters of both eyes
Changes of diopter under bright and dark pupils.
Time frame: Day 7
Use OPDScan Ⅲ to measure the parameters of both eyes.
Changes of diopter under bright and dark pupils.
Time frame: Month 1
Use OPDScan Ⅲ to measure the parameters of both eyes.
Changes of diopter under bright and dark pupils.
Time frame: Month 3
Use OPDScan Ⅲ to measure the parameters of both eyes.
Changes of diopter under bright and dark pupils.
Time frame: Month 6
Use OPDScan Ⅲ to measure the parameters of both eyes.
objective visual quality.
Time frame: Day 7
Measurement of objective visual quality using Binopotometer.
objective visual quality.
Time frame: Month 1
Measurement of objective visual quality using Binopotometer and NIDEK Automatic computerized optometry instrument（ARK-1s).
objective visual quality.
Time frame: Month 3
Measurement of objective visual quality using Binopotometer.
objective visual quality.
Time frame: Month 6
Measurement of objective visual quality using Binopotometer.
subjective visual quality
Time frame: Day 7
Using visual quality questionnaire to evaluate patients' subjective visual quality.
subjective visual quality
Time frame: Month 1
Using visual quality questionnaire to evaluate patients' subjective visual quality.
subjective visual quality
Time frame: Month 3
Using visual quality questionnaire to evaluate patients' subjective visual quality.
subjective visual quality
Time frame: Month 6
Using visual quality questionnaire to evaluate patients' subjective visual quality.
ICL Vault
Time frame: Day 7
Measuring ICL vault with Pentacam
ICL Vault
Time frame: Month 1
Measuring ICL vault with Pentacam
ICL Vault
Time frame: Month 3
Measuring ICL vault with Pentacam
ICL Vault
Time frame: Month 6
Measuring ICL vault with Pentacam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 38350161Xiong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Surgery and Visual Quality, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of diopter under bright and dark pupils. (time frame: Preoperative). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.