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

Recruiting

• Conditions: Refractive Errors; Presbyopia; Pseudophakia; Cataract
• Interventions: Diagnostic Test: Visual Acuity Assessment

• Registration Number: NCT06460389
• Lead Sponsor: Democritus University of Thrace

Brief 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-14
• Primary Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insertion of an extended depth of focus intraocular lens without digital assistance	Visual Acuity Assessment	Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance
Insertion of an extended depth of focus intraocular lens with digital assistance	Visual Acuity Assessment	Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance

Primary Outcome Measures

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

Trial Locations

Locations (1)

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