Clinical trial NCT04618380: Premium Monovision Versus Other Types of Monovision and Bilateral Trifocal Implantation.
Official title: Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Refractive Errors
Cataract
Keywords: pseudophakic presbyopic correction
premium monovision
myopic monovision
multifocal intraocular lenses
hybrid monovision
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited from the Cataract Service of the University Hospital of Alexandroupolis in a consecutive-if-eligible basis.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Binocular uncorrected distant visual acuity [bUD-VA]
timeFrame: through study completion, an average of 2.5years
measure: Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)]
timeFrame: through study completion, an average of 2.5years
measure: binocular uncorrected near reading acuity (at 40cm) [bUN-RA]
timeFrame: through study completion, an average of 2.5years
measure: binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS]
timeFrame: through study completion, an average of 2.5years
measure: binocular uncorrected near critical print size (at 40cm )[bUN-CPS]
timeFrame: through study completion, an average of 2.5years
Secondary outcomes:
measure: Dysphotopsia symptoms
timeFrame: through study completion, an average of 2.5years
measure: Contrast sensitivity
timeFrame: through study completion, an average of 2.5years
measure: Spectacle independence
timeFrame: through study completion, an average of 2.5years
measure: Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score)
timeFrame: through study completion, an average of 2.5years
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:
citation: Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.
citation: Labiris G, Panagiotopoulou EK, Perente A, Ntonti P, Delibasis K, Fotiadis I, Konstantinidis A, Dardabounis D. Premium Monovision versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation: A Comparative Study. Clin Ophthalmol. 2022 Mar 4;16:619-629. doi: 10.2147/OPTH.S351091. eCollection 2022.