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

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Cataract; Intraocular Lens Implant

Treatments: Device: Zeiss CT Asphina / Zeiss CT Asphina; Device: Zeiss AT Lara / Zeiss AT Lara; Device: Zeiss AT Lara/ Zeiss AT Lisa Tri; Device: Zeiss CT Asphina/ Zeiss AT Lara

Study type: Interventional

Funder types: Other

Identifiers

NCT05376917

2020-03-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Zeiss CT Asphina / Zeiss CT Asphina

Experimental group

Description:

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

Treatment:

Device: Zeiss CT Asphina / Zeiss CT Asphina

Zeiss AT Lara/ Zeiss AT Lisa Tri

Experimental group

Description:

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

Treatment:

Device: Zeiss AT Lara/ Zeiss AT Lisa Tri

Zeiss CT Asphina/ Zeiss AT Lara

Experimental group

Description:

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

Treatment:

Device: Zeiss CT Asphina/ Zeiss AT Lara

Zeiss AT Lara / Zeiss AT Lara

Experimental group

Description:

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

Treatment:

Device: Zeiss AT Lara / Zeiss AT Lara