Identification of Minimum Focal Points in Vision Curve Formation

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260852
• Other study ID #: ES20/Th8/23-11-2023
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 00302551030405
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia
• Pseudophakia
• Refractive Errors

Intervention

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).

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

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