Status:
COMPLETED
Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations
Lead Sponsor:
Centre Hospitalier Régional Metz-Thionville
Conditions:
Cataract
Intraocular Lens Implant
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05376917
Start Date
January 30 2023
End Date
May 21 2025
Last Update
May 28 2025
Active Locations (2)
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1
CHR Metz-Thionville/Hopital de Mercy
Metz, France, 57085
2
CHR Metz-Thionville_Hopital Bel Air
Metz, France, 57085