Trials / Completed
CompletedNCT04618380
Premium Monovision Versus Other Types of Monovision and Bilateral Trifocal Implantation.
Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Democritus University of Thrace · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | bUD-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. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-07-31
- Completion
- 2020-11-01
- First posted
- 2020-11-05
- Last updated
- 2020-11-09
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT04618380. Inclusion in this directory is not an endorsement.