Identification of Minimum Focal Points in Vision Curve Formation

Identification of Minimum Focal Points in Vision Curve Formation After Pseudophakic Presbyopia Surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06260852

Enrollment

Registered

2024-02-15

Start date

2024-02-01

Completion date

2024-08-31

Last updated

2024-03-07

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

Conditions

Cataract, Presbyopia, Pseudophakia, Refractive Errors

Keywords

pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTDiagnostic 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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Visual curves interpolation	6 months	Visual curves interpolation after visual acuity assessment in 9 focal points
Area of the curve (AOC) assessment	6 months	Calculation of the AOC after visual curve interpolation
Visual acuity assessment	6 months	Visual acuity assessment in 9 focal points using DDART chart

Countries

Greece

Contacts

Primary ContactGeorgios Labiris, MD, PhD

labiris@usa.net00302551030405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026