Identification of Minimum Focal Points in Vision Curve Formation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Presbyopia Pseudophakia Cataract Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premium presbyopia surgery

Participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation

Diagnostic Test: Visual Acuity Assessment

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age over 40,
* previous bilateral premium cataract surgery,
* best corrected visual acuity (BCVA) \< 0,2 logMAR

Exclusion Criteria

* taking topical medication to reduce intraocular pressure (IOP),
* macular diseases,
* corneal diseases,
* inability to understand the procedure,
* postoperative astigmatism \>1.50 diopters,
* postoperative clouding of the posterior capsule

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes