Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Cataract Clinical Trial

Official title:

Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460389
• Other study ID #: ES6/Th11/14-03-2024
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Democritus University of Thrace
• Contact: Georgios Labiris
• Phone: +302551030405
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

Description:

This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity & Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of grade 2 cataracts (according to LOCS III)

• age >45 years.

Exclusion Criteria:

• Inability to understand the Greek language and respond to the interview

• conditions of the posterior or corneal segment

• glaucoma

• previous intraocular surgery

Related Conditions & MeSH terms

• Cataract
• Presbyopia
• Pseudophakia
• Refractive Errors

Intervention

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 acuity assessment	Visual acuity assessment in 9 focal points using DDART chart	4 months
Primary	Area of the curve (AOC) assessment	Calculation of the AOC as a visual outscome measure	4 months
Primary	the degree of subjective satisfaction of the patient	the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)	4 months