Clinical trial NCT05494177: Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
Official title: Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Refractive Errors
Cataract
Keywords: pseudophakic presbyopic correction
premium monovision
trifocal diffractive intraocular lenses
extended depth of field intraocular lenses
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were examined at the outpatient of the Department of Ophthalmology of the University General Hospital of Alexandroupolis with the diagnosis of cataract with stage 2 (according to LOCS III) and underwent one of the following presbyopia correction surguries:

1. Bilateral implantation of trifocal diffractive intraocular lenses
2. Premium monovision with implantation of an extended depth of focus intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Binocular uncorrected distant visual acuity (bUDVA)
timeFrame: 1 year
measure: Binocular uncorrected intermediate reading acuity (bUIRA)
timeFrame: 1 year
measure: Binocular uncorrected near reading acuity (bUNRA)
timeFrame: 1 year
measure: Binocular uncorrected intermediate critical print size (bUICPS)
timeFrame: 1 year
measure: Binocular uncorrected near critical print size (bUNCPS)
timeFrame: 1 year
Secondary outcomes:
measure: Dysphotopsia symptoms
timeFrame: 1 year
measure: Contrast sensitivity
timeFrame: 1 year
measure: Spectacle independence
timeFrame: 1 year
measure: Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)
timeFrame: 1 year
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References: