Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combi… (NCT05376917) | Clinical Trial Compass
CompletedNot Applicable
Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations
France200 participantsStarted 2023-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery
Timeframe: Few days before surgery
2
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery