NCT06260852

Identification of Minimum Focal Points in Vision Curve Formation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Presbyopia
• Pseudophakia
• Cataract
• Refractive Errors

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2024-02-15
• Last updated: 2024-03-07

Locations

1 site across 1 country: Greece