Clinical trial NCT05376917: Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Intraocular Lens Implant
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery
timeFrame: Few days before surgery
measure: National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Uncorrected binocular visual acuity for far vision measured before intervention
timeFrame: Few days before surgery
measure: Uncorrected binocular visual acuity for intermediate vision measured before intervention
timeFrame: Few days before surgery
measure: Uncorrected binocular visual acuity for near vision measured before intervention
timeFrame: Few days before surgery
measure: Uncorrected binocular visual acuity for far vision measured 4 days postoperatively
timeFrame: 4 days after surgery
measure: Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively
timeFrame: 4 days after surgery
measure: Uncorrected binocular visual acuity for far vision measured 1 month postoperatively
timeFrame: 1 month after surgery
measure: Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively
timeFrame: 1 month after surgery
measure: Uncorrected binocular visual acuity for near vision measured 1 month postoperatively
timeFrame: 1 month after surgery
measure: Uncorrected binocular visual acuity for far vision measured 3 months postoperatively
timeFrame: 3 months after surgery
measure: Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively
timeFrame: 3 months after surgery
measure: Uncorrected binocular visual acuity for near vision measured 3 months postoperatively
timeFrame: 3 months after surgery
measure: Sunglasses wear frequency 3 months after surgery for far and near visions
timeFrame: 3 months after surgery
measure: Eye tonicity before surgery
timeFrame: Few days before surgery
measure: Eye tonicity 4 days postoperatively
timeFrame: 4 days after surgery
measure: Eye tonicity 1 month postoperatively
timeFrame: 1 month after surgery
measure: Eye tonicity 3 months postoperatively
timeFrame: 3 months after surgery
measure: Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery
timeFrame: Few days before surgery
measure: Slit lamp and Macular OCT examination 4 days postoperatively
timeFrame: 4 days after surgery
measure: Slit lamp and Macular OCT examination 1 month postoperatively
timeFrame: 1 month after surgery
measure: Slit lamp and Macular OCT examination 3 months postoperatively
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
city: Metz
country: France
facility: CHR Metz-Thionville_Hopital Bel Air
Study officials:
affiliation: Mercy Hospital CHR Metz Thionville
name: Jean-Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References: