An observational study in Presbyopia, Pseudophakia and Cataract, sponsored by Democritus University of Thrace. Recruiting at 1 site in Greece. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Democritus University of Thrace · Observational
The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 80 is close to the median of 88 across 52 observational studies indexed under Presbyopia.
Browse Presbyopia studies →Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
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Exclusion Criteria:
Participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
Diagnostic Test: Diagnostic Test: Visual Acuity Assessment
Uncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity \& Reading Test (DDART).
Visual curves interpolation
Visual curves interpolation after visual acuity assessment in 9 focal points
Time frame: 6 months
Area of the curve (AOC) assessment
Calculation of the AOC after visual curve interpolation
Time frame: 6 months
Visual acuity assessment
Visual acuity assessment in 9 focal points using DDART chart
Time frame: 6 months
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Democritus University of Thrace