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

Democritus University of Thrace

Status: Enrolling

Conditions: Refractive Errors; Pseudophakia; Cataract; Presbyopia

Treatments: Diagnostic Test: Visual Acuity Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06460389

ES6/Th11/14-03-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Insertion of an extended depth of focus intraocular lens with digital assistance

Description:

Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance

Treatment:

Diagnostic Test: Visual Acuity Assessment

Insertion of an extended depth of focus intraocular lens without digital assistance

Description:

Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance

Treatment:

Diagnostic Test: Visual Acuity Assessment