Visual Outcomes After Presbyopic Lens Exchange

Study Overview
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Brief Summary
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Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients

Detailed Description
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Compare preoperative and postoperative Corrected distance visual acuity

Official Title
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Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)

Conditions
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Presbyopia

Intervention / Treatment
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* Device: trifocal IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent Patients of any gender, aged 18 years or older Assured follow-up examinations Post-operative astigmatism ≤ 0.75 Diopter IOL implanted into the capsular bag with trifocal IOL in both eyes Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR Normal findings in the medical history and physical examination Exclusion Criteria: Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial Patients whose freedom is impaired by administrative or legal order Concurrent participation in another drug or device investigation that affects patients vision Signs of early cataract in either eye Preoperative monocular and binocular CDVA worse than 0.2 logMAR Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye Cataract of any grade Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, clinically significant anterior membrane dystrophies, poor pupil dilation, etc.) Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus Patient expected to require retinal laser treatment before 6 month follow-up visit Patient require refractive laser treatment / refractive laser touch-up before 6 month follow up visit Current Systemic or ocular pharmacotherapy that effects patients vision Floppy iris syndrome Monophthalmic patient Previous corneal surgery Previous use of cytotoxic drugs or total body irradiation Dementia Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of mercury (mmHg) under ocular hypertension treatment Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trifocal IOL<br>patients implanted with a trifocal intraocular lens | Device: trifocal IOL<br>* intraocular lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity | preoperative and postoperative Corrected distance visual acuity will be assessed | 4 to 6 months postop |