Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations (ELVIRA4)

Quality of Life and Uncorrected Binocular Visual Acuity (UBVA) Evaluation in Patients Undergoing Cataract Surgery Using 4 Different Types of Lens Implant Combinations: a Multicenter, Prospective, Comparative and Randomized Study

This is multicenter, prospective, comparative and randomized study focusing on the evolution of the quality of Life and Uncorrected Binocular Visual Acuity (UBVA) evaluation at 3 months after cataract surgery in patients who underwent 4 different types of intraocular lens Implant (IOL) combinations.

Study Overview

• Status: Completed
• Conditions: Cataract; Intraocular Lens Implant
• Intervention / Treatment: Device: Zeiss CT Asphina / Zeiss CT Asphina; Device: Zeiss AT Lara/ Zeiss AT Lisa Tri; Device: Zeiss CT Asphina/ Zeiss AT Lara; Device: Zeiss AT Lara / Zeiss AT Lara

Detailed Description

Cataract, linked to the loss of transparency of the lens, is the leading cause of blindness in the world. It requires exclusively surgical treatment. Cataract surgery by ultrasonic phacoemulsification is the most common surgical procedure in France (800,000/year). The lens is removed and replaced with an artificial intraocular lens.

There are different types of implants that can be used. The simplest is the monofocal implant which is implanted in such a way as to correct "only far or near vision". For near vision or vice versa, it is therefore necessary to wear corrective lenses after the operation. A technique that eliminates the need for distance and near correction is based on monovision. This is a presbyopia compensation technique that aims to induce a slight myopization of one eye for near vision (usually the dominated eye) the other eye being intended for distance vision (dominant eye). There is therefore a difference in correction and perception of the images. Depending on the fixed distance, one eye will see sharp, the other less clear, even blurry. This difference can lead to a reduction in the perception of relief.

Other methods of compensating for presbyopia include the use of so-called multifocal or extended depth of field implants; they are also not devoid of sometimes annoying side effects (in particular possible halos around light sources at night) which can lead in rare cases to the removal of the intraocular lens.

However, patient requirements in terms of comfort of vision and independence from glasses are increasingly high and patients themselves are increasingly informed of the existence of multifocal implants. The choice of the intraocular implant to use is therefore a real challenge, especially since patients are often still active on a professional level.

Moreover, there is a lack of scientific consensus related to the choice of implants, during a surgical treatment of cataract lenses by phakoexeresis, for otherwise healthy eyes and in a subject wishing to no longer wear glasses postoperatively. . Different studies have emerged comparing the bilateral implantation of different types of multifocal implants with each other, but there is little work concerning mixed batches of "mix - match" implants.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville/Hopital de Mercy
  • Metz, France, 57085
    • CHR Metz-Thionville_Hopital Bel Air

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient suffering from bilateral cataract and undergoing cataract surgery
• Patient with preoperative visual acuity ≤ 8/10th Monoyer (≥+ 0.1 logMar) in each eye
• Patient with nuclear color (NC), cortical (C) or posterior capsule opacity (P) cataract of normal to severe density in the Lens Opacities Classification System III (LOCSIII)
• Patient with cortical cataracts classified C1 to C5
• Patient with cataracts classified as nuclear opalescence (NO)1 to NO4 and nuclear color (NC)1 to NC4
• Patient with posterior capsule opacity cataracts classified as grade 5 (P1-P5)
• Patient affiliated to a social security scheme
• Patient having given written consent

Exclusion Criteria:

• Patient with biometrics ≤ 17 Diopters (D) and ≥ 28D
• Patient with a history (ATCD) of refractive surgery
• Patient with ATCD intraocular surgery
• Patient with ATCD strabismus
• Patient with amblyopia
• Patient with monophthalmos
• Patient with age-related macular degeneration (AMD)
• Patient with glaucoma
• Patient with diabetic retinopathy or maculopathy
• Patient with progressive or old ocular inflammatory disease
• Patient presenting with a very dense nuclear cataract (Stage NO5-6, NC5-6 on the LOCSIII classification), sources of preoperative complication
• Patient with keratoconus
• Patient with pseudoexfoliative syndrome
• Patient with pigment dispersion
• Patient with traumatic cataract
• Patient with astigmatism conforming to the rule > 1.5 Diopters (D) or inverse to the rule > 1 Diopter (D)
• Patient with abnormal ocular morphology
• Patient with abnormal keratometry
• Insulin-dependent diabetics and/or diabetics with retinal complications
• Pregnant or breastfeeding women
• Patient under legal protection (guardianship, curators, safeguard of justice)
• Person deprived of liberty
• Patient wishing to see near or far exclusively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zeiss CT Asphina / Zeiss CT Asphina; Monovision with refractive target of -1.50 Diopters (D) on the dominated eye	Device: Zeiss CT Asphina / Zeiss CT Asphina; Monovision with refractive target of -1.50D on the dominated eye
Experimental: Zeiss AT Lara/ Zeiss AT Lisa Tri; Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)	Device: Zeiss AT Lara/ Zeiss AT Lisa Tri; Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)
Experimental: Zeiss CT Asphina/ Zeiss AT Lara; Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)	Device: Zeiss CT Asphina/ Zeiss AT Lara; Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)
Experimental: Zeiss AT Lara / Zeiss AT Lara; Micro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye	Device: Zeiss AT Lara / Zeiss AT Lara; Micromonovision with refractive target of -0.75D on the non-dominant eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery	Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured before intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.	Few days before surgery
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery	Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured 3 months after intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire-25 (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected binocular visual acuity for far vision measured before intervention	Uncorrected binocular visual acuity for distance vision is measured before intervention using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.	Few days before surgery
Uncorrected binocular visual acuity for intermediate vision measured before intervention	Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for intermediate vision. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	Few days before surgery
Uncorrected binocular visual acuity for near vision measured before intervention	Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for near vision. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	Few days before surgery
Uncorrected binocular visual acuity for far vision measured 4 days postoperatively	Uncorrected binocular visual acuity for far vision is measured 4 days postoperatively using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.	4 days after surgery
Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively	Uncorrected binocular visual acuity for intermediate vision is measured 4 days postoperatively using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	4 days after surgery
Uncorrected binocular visual acuity for far vision measured 1 month postoperatively	Uncorrected binocular visual acuity is measured 1 month after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.	1 month after surgery
Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively	Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	1 month after surgery
Uncorrected binocular visual acuity for near vision measured 1 month postoperatively	Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	1 month after surgery
Uncorrected binocular visual acuity for far vision measured 3 months postoperatively	Uncorrected binocular visual acuity is measured 3 months after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.	3 months after surgery
Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively	Uncorrected binocular visual acuity for intermediate vision is measured 3 months after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	3 months after surgery
Uncorrected binocular visual acuity for near vision measured 3 months postoperatively	Uncorrected binocular visual acuity for near vision is measured 3 months after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).	3 months after surgery
Sunglasses wear frequency 3 months after surgery for far and near visions	Frequency of wearing sunglasses in patients undergoing IOL implant surgery : permanently (yes/no) or occasionally (yes/no) for far and near visions	3 months after surgery
Eye tonicity before surgery	Eye pressure measurement millimeters of mercury (mmHg) before intervention	Few days before surgery
Eye tonicity 4 days postoperatively	Eye pressure measurement millimeters of mercury (mmHg) 4 days postoperatively	4 days after surgery
Eye tonicity 1 month postoperatively	Eye pressure measurement millimeters of mercury (mmHg) 1 month postoperatively	1 month after surgery
Eye tonicity 3 months postoperatively	Eye pressure measurement millimeters of mercury (mmHg) 3 months postoperatively	3 months after surgery
Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery	Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)	Few days before surgery
Slit lamp and Macular OCT examination 4 days postoperatively	Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)	4 days after surgery
Slit lamp and Macular OCT examination 1 month postoperatively	Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)	1 month after surgery
Slit lamp and Macular OCT examination 3 months postoperatively	Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)	3 months after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Jean-Marc PERONE, MD, Mercy Hospital CHR Metz Thionville

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2020-03-CHRMT

Drug and device information, study documents

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