Identification of Minimum Focal Points in Vision Curve Formation

Recruiting

• Conditions: Presbyopia; Pseudophakia; Cataract; Refractive Errors

• Registration Number: NCT06260852
• Lead Sponsor: Democritus University of Thrace

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity assessment	6 months	Visual acuity assessment in 9 focal points using DDART chart
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

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece