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

NCT05494177 | Completed DMC

• 1 other identifier: ES13/Th7/07-07-2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Refractive Errors; Cataract

Keywords

pseudophakic presbyopic correction; premium monovision; trifocal diffractive intraocular lenses; extended depth of field intraocular lenses

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Dysphotopsia symptoms

  1 year

• Contrast sensitivity

  1 year

• Spectacle independence

  1 year

• Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)

  1 year

Study Arms (2)

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; Diagnostic Test: Contrast sensitivity

Bilateral trifocal diffractive implantation

Patients will undergo to bilateral implantation of trifocal diffractive lenses.

Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity

Interventions

bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS DIAGNOSTIC_TEST

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).

Bilateral trifocal diffractive implantation; Premium monovision

Contrast sensitivity DIAGNOSTIC_TEST

Contrast sensitivity is assessed with the Pelli-Robson test.

Bilateral trifocal diffractive implantation; Premium monovision

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
• Age\>45 years

You may not qualify if:

• Disability to understand the Greek language and respond to the interview
• Fundus or corneal diseases
• Glaucoma
• Previous intraocular surgery

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

• Labiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336.

  PMID: 37847127 DERIVED

MeSH Terms

Conditions

Presbyopia; Refractive Errors; Cataract

Interventions

Contrast Sensitivity

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Visual Acuity; Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Georgios Labiris, MD, PhD

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2022-08

Locations

GR (1)