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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.

Conditions
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Presbyopia, Refractive Errors, Cataract

Intervention / Treatment
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* Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral trifocal implantation<br>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<br>* The following clinical indexes are evaluated: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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.<br>|
| Myopic monovision<br>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<br>* The following clinical indexes are evaluated: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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.<br>|
| Hybrid monovision<br>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<br>* The following clinical indexes are evaluated: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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.<br>|
| Premium monovision<br>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<br>* The following clinical indexes are evaluated: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphotopsia symptoms | Dysphotopsia is evaluated with two direct 4-scale, Likert-type questions (Always, Most of the times, Sometimes, Never) pertaining on the subjective perception of glare and unwanted shadows. This parameter is obtained six months following the operation of the second eye. | through study completion, an average of 2.5years | 
| Contrast sensitivity | Contrast sensitivity is evaluated with the Pelli-Robson test. This parameter is obtained six months following the operation of the second eye. | through study completion, an average of 2.5years | 
| Spectacle independence | Spectacle dependence is also evaluated for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never). This parameter is obtained six months following the operation of the second eye. | 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) | Subjective satisfaction rates are assessed using the prevalent VF-14 instrument. Further to the total VF-14 score assessment, two additional scores are calculated: a) Near vision VF score (VF14-NV) derived from items that assess the perceived difficulty in near vision activities (items 1,2,3,7,8,9 and 11), and, b) Distant vision VF score (VF14-DV) derived from items that assess the perceived difficulty of distant vision activities (items 4, 5, 6, 10, 12, 13 and 14). VF-14 has a final score from 0 to 100. A score of 100 indicates able to do all applicable activities. A score of 0 indicates unable to do all applicable activities because of vision. | through study completion, an average of 2.5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pseudophakic presbyopic correction, premium monovision, myopic monovision, multifocal intraocular lenses, hybrid monovision