PREVALENCE AND TYPES OF ABERRATIONS IN EYES WITH SUPERVISION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
Patient preparation and examination:
- Full ophthalmic examination: Perform standard comprehensive eye exam including
· Refractive status- UCVA, BCVA
· Slit lamp examination, IOP and Dilated fundus examination
- Aberrometry (Primary Test)(HOYA Itrace surgical workstation USA)
Key parameters captured:
· Total HOA (RMS)
· Corneal HOA (RMS)
· Internal HOA (RMS)
· Zernike coefficients up to 6th order
· Specific aberrations of interest:
o Coma (vertical, horizontal)
o Trefoil
o Spherical aberration
o Secondary astigmatism
· Topography
· Placido-disc corneal topography from iTrace
· Keratometry values
· Cone-like irregularities (if any)
· Quality Control
· Minimum of 3 scans per eye, best-quality scan used
· Pupil size documented for each scan
Participants will be divided based on their refractive status into:
Group 1: untreated UCVA 6/4 or better
Group 2: BCVA 6/4 or better
Group 3: post corneal refractive surgery with 6/4 or better
OUTCOME MEASURES
Primary Outcome
- Mean and distribution of total, corneal, and internal HOA RMS values in super-normal–vision eyes.
Secondary Outcomes
- Relationship between individual HOAs and UCVA (correlation analysis).
- Differences in HOA patterns across refractive groups.
- Proportion of subjects with “favorable” HOA profiles (e.g., negative spherical aberration).
DATA COLLECTION AND EXTRACTION:
Data should be extracted from iTrace software reports and recorded in study database (eg excel, red cap)
• Patient demographics: Age, gender, study ID;
• Refractive data (low order aberrations LOA); Aberration metrics: record the root mean square values for relevant aberrations, typically for a fixed pupil diameter.
STATISTICAL ANALYSIS METHODOLOGY:
All analyses will be conducted using Python (v3.12) and Jamovi (v2.5). Group differences will be assessed using a one-way fixed-effect ANOVA, with normality evaluated using the Kolmogorov–Smirnov test and homogeneity of variances tested using Levene’s test. Continuous data will be presented as mean ± SD, and categorical data as frequencies and percentages. When the ANOVA is significant, Bonferroni-adjusted post hoc tests will be performed. When normality assumptions are not met, appropriate non-parametric tests will be applied. A two-tailed p-value < 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients with UCVA 6/4 or better.
- •Patients with 6/4 or better vision status post corneal refractive procedure.
排除标准
- •Any ocular pathology (keratoconus, corneal scars, cataract, glaucoma, retinal disease) Prior cataract surgery Contact lens wear within the last 48 hours (soft) / 2 weeks (RGP) Systemic diseases affecting the eye Poor fixation, inability to perform iTrace scan Pupillary abnormality Dry eyes or ocular surface diseases.
研究者
DR SRI GANESH
Nethradhama superspeciality eye hospital
