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The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premium presbyopia surgery | Participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: Visual Acuity Assessment | Diagnostic Test | Uncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity & Reading Test (DDART). |
| Measure | Description | Time Frame |
|---|---|---|
| Visual curves interpolation | Visual curves interpolation after visual acuity assessment in 9 focal points | 6 months |
| Area of the curve (AOC) assessment | Calculation of the AOC after visual curve interpolation | 6 months |
| Visual acuity assessment | Visual acuity assessment in 9 focal points using DDART chart | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Labiris, MD, PhD | Contact | 00302551030405 | labiris@usa.net |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, PhD | Democritus University of Thrace | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D019591 | Pseudophakia |
| D002386 | Cataract |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
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