NCT06460389

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Presbyopia
• Pseudophakia
• Cataract
• Refractive Errors

Interventions

Type	Name	Description
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: 2024-01-01
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2024-06-14
• Last updated: 2026-02-24

Locations

1 site across 1 country: Greece