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

NCT04618380 | Completed DMC

• 1 other identifier: ES13/Th9/22-10-2020
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Refractive Errors; Cataract

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Binocular uncorrected distant visual acuity [bUD-VA]

  bUD-VA is obtained using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance. This parameter is obtained six months following the operation of the second eye.

  through study completion, an average of 2.5years

• Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)]

  bUI-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.

  through study completion, an average of 2.5years

• binocular uncorrected near reading acuity (at 40cm) [bUN-RA]

  bUN-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.

  through study completion, an average of 2.5years

• binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS]

  bUI-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.

  through study completion, an average of 2.5years

• binocular uncorrected near critical print size (at 40cm )[bUN-CPS]

  bUN-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.

  through study completion, an average of 2.5years

Secondary Outcomes (4)

• Dysphotopsia symptoms

  through study completion, an average of 2.5years

• Contrast sensitivity

  through study completion, an average of 2.5years

• Spectacle independence

  through study completion, an average of 2.5years

• Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score)

  through study completion, an average of 2.5years

Study Arms (4)

Bilateral trifocal implantation

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

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

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)

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

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

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

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.

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

Interventions

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

Bilateral trifocal implantation; Hybrid monovision; Myopic monovision; Premium monovision

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were recruited from the Cataract Service of the University Hospital of Alexandroupolis in a consecutive-if-eligible basis.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (2)

• 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.

  PMID: 33102611 RESULT

• 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.

  PMID: 35282170 DERIVED

MeSH Terms

Conditions

Presbyopia; Refractive Errors; Cataract

Interventions

Contrast Sensitivity

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Visual Acuity; Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Georgios Labiris, MD,PHD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 5, 2020
• Study Start: January 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: November 1, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

GR (1)