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

NCT ID: NCT06460389

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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

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Presbyopia Pseudophakia Cataract Refractive Errors

Keywords

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pseudophakic presbyopic correction extended depth of field intraocular lenses visual curve visual acuity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Visual Acuity Assessment

Intervention Type DIAGNOSTIC_TEST

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).

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

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

Visual Acuity Assessment

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris

Role: STUDY_CHAIR

Democritus University of Thrace

Locations

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Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Georgios Labiris

Role: CONTACT

Phone: +302551030405

Email: [email protected]

Eirini-Kanella Panagiotopoulou, MD, PhD

Role: CONTACT

Phone: +302551030405

Email: [email protected]

Facility Contacts

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Georgios Labiris, MD, PhD

Role: primary

Other Identifiers

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ES6/Th11/14-03-2024

Identifier Type: -

Identifier Source: org_study_id