Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Democritus University of Thrace

Status: Completed

Conditions: Refractive Errors; Cataract; Presbyopia

Treatments: Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity

Study type: Observational

Funder types: Other

Identifiers

NCT05494177

ES13/Th7/07-07-2022

Details and patient eligibility

About

Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

Full description

Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Enrollment: 100 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
• Age>45 years

Exclusion criteria

• Disability to understand the Greek language and respond to the interview
• Fundus or corneal diseases
• Glaucoma
• Previous intraocular surgery

Trial design

100 participants in 2 patient groups

Premium monovision

Description:

Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye.

Treatment:

Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS

Diagnostic Test: Contrast sensitivity

Bilateral trifocal diffractive implantation

Description:

Patients will undergo to bilateral implantation of trifocal diffractive lenses.

Treatment:

Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS

Diagnostic Test: Contrast sensitivity