Identification of Minimum Focal Points in Vision Curve Formation

Democritus University of Thrace

Status: Enrolling

Conditions: Refractive Errors; Pseudophakia; Cataract; Presbyopia

Treatments: Diagnostic Test: Diagnostic Test: Visual Acuity Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06260852

ES20/Th8/23-11-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Premium presbyopia surgery

Description:

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

Treatment:

Diagnostic Test: Diagnostic Test: Visual Acuity Assessment