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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Cataract; Presbyopia
• Intervention / Treatment: Diagnostic test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic test: Contrast sensitivity

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Premium monovision; Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye.	Diagnostic test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; All participants will be assessed on the following clinical indexes: Binocular uncorrected distant visual acuity (bUDVA) at four meters distance; Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm; Binocular uncorrected near reading acuity (bUNVA) at 40 cm; Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm; 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.
Bilateral trifocal diffractive implantation; Patients will undergo to bilateral implantation of trifocal diffractive lenses.	Diagnostic test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; All participants will be assessed on the following clinical indexes: Binocular uncorrected distant visual acuity (bUDVA) at four meters distance; Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm; Binocular uncorrected near reading acuity (bUNVA) at 40 cm; Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected distant visual acuity (bUDVA)	bUDVA is obtained using the distance vision test of DDART at four meters distance.	1 year
Binocular uncorrected intermediate reading acuity (bUIRA)	bUIRA is obtained using the near vision test of DDART at 60 cm distance.	1 year
Binocular uncorrected near reading acuity (bUNRA)	bUNRA is obtained using the near vision test of DDART at 40 cm distance.	1 year
Binocular uncorrected intermediate critical print size (bUICPS)	bUICPS is obtained using the near vision test of DDART at 60 cm distance.	1 year
Binocular uncorrected near critical print size (bUNCPS)	bUNCPS is obtained using the near vision test of DDART at 40 cm distance.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphotopsia symptoms	Dysphotopsia is evaluated with two direct 4-scale, Likert-type questions (Always, Most of the times, Sometimes, Never) assessing subjective appearance of glare and halos.	1 year
Contrast sensitivity	Contrast sensitivity is evaluated with the Pelli-Robson test.	1 year
Spectacle independence	Spectacle dependence is assessed for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never).	1 year
Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)	Subjective satisfaction rates are assessed using the prevalent VF-14 questionnaire. Further to the total VF-14 score assessment, two additional scores are calculated: a) Near vision VF score (VF14-NV) derived from items that assess the perceived difficulty in near vision activities (items 1,2,3,7,8,9 and 11), and, b) Distant vision VF score (VF14-DV) derived from items that assess the perceived difficulty of distant vision activities (items 4, 5, 6, 10, 12, 13 and 14). VF-14 has a final score from 0 to 100. A score of 100 indicates able to do all applicable activities. A score of 0 indicates unable to do all applicable activities because of vision.	1 year

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Chair: Georgios Labiris, MD, PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 6, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pseudophakic presbyopic correction; premium monovision; trifocal diffractive intraocular lenses; extended depth of field intraocular lenses
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: ES13/Th7/07-07-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No