Cataract, Presbyopia, Refractive Errors
Conditions
Keywords
pseudophakic presbyopic correction, premium monovision, myopic monovision, multifocal intraocular lenses, hybrid monovision
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 .
Interventions
DIAGNOSTIC_TESTbUD-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.
Sponsors
Democritus University of Thrace
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| binocular uncorrected near critical print size (at 40cm )[bUN-CPS] | through study completion, an average of 2.5years | 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. |
| Binocular uncorrected distant visual acuity [bUD-VA] | through study completion, an average of 2.5years | 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. |
| Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)] | through study completion, an average of 2.5years | 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. |
| binocular uncorrected near reading acuity (at 40cm) [bUN-RA] | through study completion, an average of 2.5years | 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. |
| binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS] | through study completion, an average of 2.5years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysphotopsia symptoms | through study completion, an average of 2.5years | 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. |
| Spectacle independence | through study completion, an average of 2.5years | 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. |
| 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 | 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. |
| Contrast sensitivity | through study completion, an average of 2.5years | Contrast sensitivity is evaluated with the Pelli-Robson test. This parameter is obtained six months following the operation of the second eye. |
Countries
Greece
Outcome results
None listed