An observational study in Cataract and Near Vision, sponsored by Yune Zhao. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Yune Zhao · Observational
The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation
ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00：1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 30 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.
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From December 2019 to present, cataract patients underwent phacoemulsification combined with ZXR00 IOLs or ZMB00 IOLs implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).
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Exclusion Criteria:
The bilateral implantation of ZXR00 IOLs，and emmetropia was considered as the target refraction for both eyes.
The bilateral implantation of ZXR00 IOLs，and the ZXR00 IOLs power calculations were performed using a micro-monovision approach aiming for minimal residual myopia (≈ -0.50 D) in the nondominant eye and emmetropia in the dominant eye.
The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs.
Uncorrected Visual Acuities
Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Time frame: 2022.12.31
Corrected Visual Acuities
Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Time frame: 2022.12.31
Defocus Curve
Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps).
Time frame: 2022.12.31
Patient satisfaction
Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied.
Time frame: 2022.12.31
Subjective quality of vision
Subjective quality of vision was evaluated using the 14-item Visual Function Questionnaire (VFQ-14).Each item was scaled according to the degree of difficulty of different activities: 4 points (no difficulty), 3 points (a little difficulty), 2 points (a moderate amount of difficulty), 1 point (a great deal of difficulty), and 0 point (unable to do the activity).overall score is range 0-56.The higher the score, the worse subjective quality of vision.
Time frame: 2022.12.31
Adverse visual symptoms
Adverse visual symptoms including blurred vision, glare, starbursts, haloes, hazy vision, distortion, focusing diffculties, multiple images, and depth perception diffculty, was evaluated using the Quality of Vision test. This test includes 30 items, with a score between 0 and 3 (overall score range 0-90).The higher the score, the more postoperative adverse visual symptoms.
Time frame: 2022.12.31
Stereopsis
Stereopsis was evaluated using OCULUS Binoptometer.
Time frame: 2022.12.31
No study locations are listed for this record.
Start is estimated for Nov 2022; primary completion for Dec 2022, 1 month later.
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Yune Zhao