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

NCT ID: NCT05376917

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2025-05-21

Brief Summary

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.

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.

Conditions

Cataract; Intraocular Lens Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Zeiss CT Asphina / Zeiss CT Asphina

Monovision with refractive target of -1.50 Diopters (D) on the dominated eye

Group Type: EXPERIMENTAL

Zeiss CT Asphina / Zeiss CT Asphina

Intervention Type: DEVICE

Monovision with refractive target of -1.50D on the dominated eye

Zeiss AT Lara/ Zeiss AT Lisa Tri

Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)

Group Type: EXPERIMENTAL

Zeiss AT Lara/ Zeiss AT Lisa Tri

Intervention Type: DEVICE

Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)

Zeiss CT Asphina/ Zeiss AT Lara

Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)

Group Type: EXPERIMENTAL

Zeiss CT Asphina/ Zeiss AT Lara

Intervention Type: DEVICE

Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)

Zeiss AT Lara / Zeiss AT Lara

Micro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye

Group Type: EXPERIMENTAL

Zeiss AT Lara / Zeiss AT Lara

Intervention Type: DEVICE

Micromonovision with refractive target of -0.75D on the non-dominant eye

Interventions

Zeiss CT Asphina / Zeiss CT Asphina

Monovision with refractive target of -1.50D on the dominated eye

Intervention Type: DEVICE

Zeiss AT Lara/ Zeiss AT Lisa Tri

Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)

Intervention Type: DEVICE

Zeiss CT Asphina/ Zeiss AT Lara

Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)

Intervention Type: DEVICE

Zeiss AT Lara / Zeiss AT Lara

Micromonovision with refractive target of -0.75D on the non-dominant eye

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc PERONE, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital CHR Metz Thionville

Locations

CHR Metz-Thionville/Hopital de Mercy

Metz, , France

CHR Metz-Thionville_Hopital Bel Air

Metz, , France

Countries

France

Other Identifiers

2020-03-CHRMT

Identifier Type: -

Identifier Source: org_study_id