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

NCT ID: NCT04618380

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-11-01

Brief Summary

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.

Detailed 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 .

Conditions

Presbyopia; Refractive Errors; Cataract

Keywords

pseudophakic presbyopic correction; premium monovision; myopic monovision; multifocal intraocular lenses; hybrid monovision

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral trifocal implantation

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

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Intervention Type: DIAGNOSTIC_TEST

The following clinical indexes are evaluated:

1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and

3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

Myopic monovision

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)

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Intervention Type: DIAGNOSTIC_TEST

The following clinical indexes are evaluated:

1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and

3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

Hybrid monovision

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

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Intervention Type: DIAGNOSTIC_TEST

The following clinical indexes are evaluated:

1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and

3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

Premium monovision

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.

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Intervention Type: DIAGNOSTIC_TEST

The following clinical indexes are evaluated:

1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and

3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

Interventions

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

The following clinical indexes are evaluated:

1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and

3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Labiris, MD,PHD

Role: STUDY_CHAIR

Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Locations

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Countries

Greece

References

Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.

Reference Type: RESULT

PMID: 33102611 (View on PubMed)

Labiris G, Panagiotopoulou EK, Perente A, Ntonti P, Delibasis K, Fotiadis I, Konstantinidis A, Dardabounis D. Premium Monovision versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation: A Comparative Study. Clin Ophthalmol. 2022 Mar 4;16:619-629. doi: 10.2147/OPTH.S351091. eCollection 2022.

Reference Type: DERIVED

PMID: 35282170 (View on PubMed)

Other Identifiers

ES13/Th9/22-10-2020

Identifier Type: -

Identifier Source: org_study_id