Prospective Clinical Trial of Unilateral or Bilateral Implantation of TecnisSymfony IOL in Cataract Patients With Presbyopia

Study Overview
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Brief Summary
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This is to evaluate the satisfaction of patient and physician about short-distance, medium-distance, long-distance postoperative vision and eyeglass dependence, glare, and visual acuity after insertion of the TECNIS® Symfony or TECNIS® Symfony Toric intraocular lens.

Detailed Description
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The patients underwent uneventful phacoemulsification and implantation of TecnisSymfony®. Mean absolute error (MAE) at 1 month was compared in SRK/T, Holladay2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formula. At postoperative 1, 4, and 12 weeks, logMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm), and spherical equivalent (SE) in manifested refraction (MR) and automated refraction (AR) were measured. Wavefront aberration, contrast sensitivity test, and glare test were done at 12 weeks. The questionnaire was used to investigate glare, glasses dependency, and patient satisfaction at 12 weeks.

Official Title
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Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: TecnisSymfony®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral or bilateral cataract Sixteen years and older Regular corneal topography and corneal astigmatism Corneal astigmatism 0.75 Diopter and less for TECNIS® Symfony IOL, and between 1.0 and 3.62 Diopter for TECNIS® Symfony toric IOL Exclusion Criteria: Pregnant or nursing women In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Malfan syndrome, etc.) White cataract Patients who need intraocular lens outside of range In the presence of other ocular diseases that is expected to have a poor final visual acuity of less than 20/30 after surgery (amblyopia, strabismus, keratoconus, etc.) Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.) Patients using systemic or ocular medication that affect visual acuity. Patients who had previously undergone refractive surgery. Patients participating in other clinical trials during the study.

Ages Eligible for Study
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Minimum Age: 16 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: TecnisSymfony intraocular lens insertion group<br> | Device: TecnisSymfony®<br>* Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of visual acuity at near, intermediate and far | LogMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm) were measured at preoperative (last outpatient follow-up before the surgery), postoperative 1, 4, and 12 weeks. | preoperative(last outpatient follow-up before the surgery), 1 month after surgery, 3 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photic phenomena evaluation by questionnaire. | Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe). | One month and three months after the surgery. | 
| Spectacle dependence evaluation by questionnaire | Patients were asked for 0, 25, 50, 75, and 100% of the need to wear glasses at distance, mid-range, and near distance. | One month and three months after the surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenses, Intraocular