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A Comparison of Nighttime Visual Quality in Patients with Moderate to High Myopia Corrected with IntraocularLenses Following V4c and PR Posterior Chamber Implantation: A Prospective Observational Cohort Study

A Comparison of Nighttime Visual Quality in Patients with Moderate to High Myopia Corrected with IntraocularLenses Following V4c and PR Posterior Chamber Implantation: A Prospective Observational Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125572
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractive errors

Interventions

Group V4c:None
Group PR:None

Sponsors

Nanchang Bright Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients can be enrolled only if they meet all of the following criteria simultaneously: 1. Age 18–45 years (inclusive); 2. Indicated for intraocular lens implantation in the posterior chamber according to V4c or PR models; 3. Spherical equivalent (SE) between -3.00D and -12.00D; astigmatism range according to clinical indications; 4. Refractive change =20/30 (or logMAR =2.8 mm; intraocular pressure 10–21 mmHg, open anterior chamber angle; corneal topography/tomography shows no keratoconus or suspected ectasia; corneal endothelial cell density (ECD) >=2200 cells/mm^2 or meets the hospital's age-stratified criteria; 7. Able to complete the original English QoV questionnaire under standardized guidance by study personnel and provide written informed consent.

Exclusion criteria

Exclusion criteria: Individuals meeting any of the following criteria are not eligible to participate: 1. History of corneal refractive surgery, corneal transplantation, cataract surgery, or other significant intraocular surgeries; 2. Active eye diseases that affect examination or postoperative recovery, including but not limited to uveitis, severe keratoconjunctivitis, and active allergic conjunctivitis; 3. Angle-closure/narrow-angle glaucoma, confirmed glaucoma, or requiring long-term intraocular pressure-lowering treatment; 4. Significant cataract, lens subluxation, abnormal suspensory ligaments, or other lens abnormalities; 5. Corneal scars, keratoconus, or suspected ectasia and other corneal conditions unsuitable for implantation; 6. Retinal or macular diseases that significantly affect visual prognosis; 7. Pregnancy or breastfeeding; uncontrolled diabetes, hypertension, or systemic diseases affecting wound healing/inflammation control; immune system disorders or long-term immunosuppressive therapy; 8. Inability to complete the 3-month postoperative primary endpoint follow-up, or missing critical baseline variables (such as preoperative refraction, ACD, WTW, preoperative QoV, etc.); 9. Other circumstances deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
3-month postoperative Quality of Vision (QoV) overall score;

Secondary

MeasureTime frame
QoV subscale scores (frequency, severity, bothersome);Glare score;Halo score;Starburst score;Postoperative uncorrected distance visual acuity (UDVA);Postoperative spherical equivalent (SE);Postoperative residual cylinder;Postoperative vault;Postoperative intraocular pressure (IOP);Postoperative endothelial cell density (ECD);Postoperative total higher-order aberrations (HOAs);Postoperative spherical aberration;Postoperative vertical coma;Postoperative horizontal coma;

Countries

China

Contacts

Public ContactHui Zhang

Nanchang Bright Eye Hospital

hahaalsace@163.com+86 183 2297 1520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026