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

Completed

• Conditions: Refractive Errors; Cataract; Presbyopia
• Interventions: Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity

• Registration Number: NCT05494177
• Lead Sponsor: Democritus University of Thrace

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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-06
• Study First Posted: 2022-08-09
• Primary Completion: 2022-12-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premium monovision	bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS	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.
Premium monovision	Contrast sensitivity	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.
Bilateral trifocal diffractive implantation	bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS	Patients will undergo to bilateral implantation of trifocal diffractive lenses.
Bilateral trifocal diffractive implantation	Contrast sensitivity	Patients will undergo to bilateral implantation of trifocal diffractive lenses.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Spectacle independence	1 year	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).
Dysphotopsia symptoms	1 year	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.
Contrast sensitivity	1 year	Contrast sensitivity is evaluated with the Pelli-Robson test.
Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)	1 year	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.

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece