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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral trifocal implantation | Bilateral implantation of trifocal diffractive intraocular lenses (Panoptix, Alcon) targeting emmetropia |
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| 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) |
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| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity | Diagnostic Test | The following clinical indexes are evaluated:
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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited from the Cataract Service of the University Hospital of Alexandroupolis in a consecutive-if-eligible basis.
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD,PHD | Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Hospital of Alexandroupolis | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33102611 | Result | 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. | |
| 35282170 | Derived | 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. |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D015350 | Contrast Sensitivity |
| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D003933 | Diagnosis |
| D009799 | Ocular Physiological Phenomena |