Premium Monovision Versus Other Types of Monovision and Bilateral Trifocal Implantation.

Democritus University of Thrace

Status: Completed

Conditions: Refractive Errors; Cataract; Presbyopia

Treatments: Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Study type: Observational

Funder types: Other

Identifiers

NCT04618380

ES13/Th9/22-10-2020

Details and patient eligibility

About

Primary objective of this study was to compare the efficacy of premium monovision with Restor and Panoptix, against other prevalent monovision techniques and against bilateral Panoptix implantation in a sample of patients following lens-extraction surgery.

Full description

Four study groups were formed according to the procedure and the intraocular lens technology that was used: a) Monovision Group (MoG), b) Multifocal Lens Group (MfG), c) Hybrid Monovision Group (HmG), and, d) Premium Monovision Group (PmG). Patients who have undergone one of the above categories of presbyopia correction surgery were selected to compare the effectiveness of these techniques by evaluating the uncorrected near, intermediate and distant visual acuity as well as the degree of subjective patient satisfaction, contrast sensitivity, dysphotopsia symptoms and spectacle independence .

Enrollment: 120 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion criteria

• Manifest astigmatism > 1.00 diopters
• Reports of headaches and/or eyestrain associated with visual activities
• Positive, pathologic ocular cover test (near & distant) and / or the Mallett's disparity test (near & distant) and the double Maddox rod test
• Endothelial cell count less than 1900/mm2
• Glaucoma
• intraocular pressure-lowering medications
• Former incisional surgery
• Former diagnosis of corneal disease
• Former diagnosis of fundus disease
• Diabetes
• Autoimmune diseases
• Mental diseases

Trial design

120 participants in 4 patient groups

Bilateral trifocal implantation

Description:

Bilateral implantation of trifocal diffractive intraocular lenses (Panoptix, Alcon) targeting emmetropia

Treatment:

Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Myopic monovision

Description:

The dominant eye defocus is targeted to -0.50 diopters while the recessive one to -1.25 diopters with bilateral implantation of monofocal intraocular lenses (SN60WF, Alcon)

Treatment:

Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Hybrid monovision

Description:

Hybrid monovision combines a monofocal intraocular (SN60WF, Alcon) in the dominant eye and a trifocal diffractive intraocular lens (Panoptix, Alcon) in the recessive one

Treatment:

Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Premium monovision

Description:

Participants received a bifocal hybrid (refractive at the centre, diffractive at the periphery) intraocular lens (Restor +2.50 diopters, Alcon) in the dominant eye and a trifocal diffractive intraocular lens (Panoptix, Alcon) in the recessive one, targeting emmetropia in both eyes.

Treatment:

Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity