Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Study Overview
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Brief Summary
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Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

Detailed Description
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Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Official Title
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Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Conditions
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Presbyopia, Refractive Errors, Cataract

Intervention / Treatment
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* Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS
* Diagnostic Test: Contrast sensitivity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale Age>45 years Exclusion Criteria: Disability to understand the Greek language and respond to the interview Fundus or corneal diseases Glaucoma Previous intraocular surgery

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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 |
| --- | --- |
| Premium monovision<br>Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye. | Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS<br>* All participants will be assessed on the following clinical indexes: Binocular uncorrected distant visual acuity (bUDVA) at four meters distance Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm Binocular uncorrected near reading acuity (bUNVA) at 40 cm Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm All the above parameters are obtained using the Democritus Digital Acuity & Reading Test (DDART).<br>Diagnostic Test: Contrast sensitivity<br>* Contrast sensitivity is assessed with the Pelli-Robson test.<br>|
| Bilateral trifocal diffractive implantation<br>Patients will undergo to bilateral implantation of trifocal diffractive lenses. | Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS<br>* All participants will be assessed on the following clinical indexes: Binocular uncorrected distant visual acuity (bUDVA) at four meters distance Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm Binocular uncorrected near reading acuity (bUNVA) at 40 cm Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm All the above parameters are obtained using the Democritus Digital Acuity & Reading Test (DDART).<br>Diagnostic Test: Contrast sensitivity<br>* Contrast sensitivity is assessed 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 (bUDVA) | bUDVA is obtained using the distance vision test of DDART at four meters distance. | 1 year | 
| Binocular uncorrected intermediate reading acuity (bUIRA) | bUIRA is obtained using the near vision test of DDART at 60 cm distance. | 1 year | 
| Binocular uncorrected near reading acuity (bUNRA) | bUNRA is obtained using the near vision test of DDART at 40 cm distance. | 1 year | 
| Binocular uncorrected intermediate critical print size (bUICPS) | bUICPS is obtained using the near vision test of DDART at 60 cm distance. | 1 year | 
| Binocular uncorrected near critical print size (bUNCPS) | bUNCPS is obtained using the near vision test of DDART at 40 cm distance. | 1 year | 

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) assessing subjective appearance of glare and halos. | 1 year | 
| Contrast sensitivity | Contrast sensitivity is evaluated with the Pelli-Robson test. | 1 year | 
| Spectacle independence | Spectacle dependence is assessed for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never). | 1 year | 
| Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score) | Subjective satisfaction rates are assessed using the prevalent VF-14 questionnaire. 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses