NCT05494177

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Presbyopia
• Refractive Errors
• Cataract

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS	All participants will be assessed on the following clinical indexes: 1. Binocular uncorrected distant visual acuity (bUDVA) at four meters distance 2. Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm 3. Binocular uncorrected near reading acuity (bUNVA) at 40 cm 4. Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm 5. Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART).
DIAGNOSTIC_TEST	Contrast sensitivity	Contrast sensitivity is assessed with the Pelli-Robson test.

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2022-08-09
• Last updated: 2023-06-18

Locations

1 site across 1 country: Greece