Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment

Study Overview
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Brief Summary
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The aim of this study is to assess visual and refractive outcomes after Toric Trifocal lens implantation and visual outcomes after laser vision correction (LVC) - ReLex Smile to correct residual refraction after 6 months of Toric Trifocal (IOL) implantation.

Detailed Description
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The current state of the art for the correction of aphakia and presbyopia after lens extraction and refractive lensectomy is the implantation of multifocal intraocular lenses (IOL). In this study, the trifocal IOL types AT LISA TRI 839MP and AT LISA TRI TORIC 939MP (Carl Zeiss Meditec, Germany) were assessed. In this prospective non-randomized study patients with spherical hypermetropia of >4 D in combination with high astigmatism of >3.0 D were treated. The first group of 40 eyes of 20 patients underwent refractive lensectomy, followed by implantation of the diffractive trifocal IOL type AT LISA TRI 839MP (Carl Zeiss Meditec, Jena, Germany) and 6 months later SMILE surgery. In 40 eyes of 20 patients in the second group IOL type AT LISA TRI TORIC 939MP were implanted. All patients were adequately consulted preoperatively about this type of IOLs and they were verbally consented. The study is adherent to the tenets of the Declaration of Helsinki. All patient are between 20- 45 years old. The current study demonstrates that both the non-toric and toric versions of the trifocal IOL evaluated here provide excellent functional vision to patients, with good distance, intermediate and near uncorrected VA, a wide range of vision and good contrast sensitivity. Before SMILE,Yag-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the Yag-Laser is applied after the Smile, there will be a diopter change. Relex Smile surgery in pseudophakic patients with trifocal IOL was safe, effective, and predictable in a large cohort of patients. It is noteworthy that the decision for a treatment strategy (toric IOL or non-toric IOL with SMILE in s second step) should be made carefully, to select the appropriate method for the patient. During phaco surgey the positions of incisions should be determined according to the angle of the highest K value of the patient. For high astigmatic patients, toric trifocal IOL is highly effective.

Official Title
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Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment With High Astigmatism and Hyperopia

Conditions
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Astigmatism High Both, Pseudophakia, Hyperopia

Intervention / Treatment
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* Procedure: Toric Trifocal IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High spherical hypermetropia Astigmatismus >2 D or higher Amblyopia Strabismus (accomodative esotropia) Exclusion Criteria: Glaucoma Retinal detachment Corneal disease Macular degeneration Advanced Retinopathy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups divided in 40 eyes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toric Trifocal IOL<br>Twenty patients (20) underwent Toric Trifocal IOL surgery (first group) | Procedure: Toric Trifocal IOL<br>* Interventions are performed using a standard technique of sutureless phacoemulsification. In all cases, topical anesthesia was administered and pharmacologic mydriasis was induced using a combination of tropicamide and phenylephrine (10.0%). A mean clear corneal microincision of 2.2 mm was made with a knife according to position of the preop highest K value of the patient. A paracentesis was made 60 degree to 80 degree, clockwise from the main incision, and the anterior chamber was filled with an ophthalmic viscoelastic (OVD) after phacoemulsification/lensectomy and removal of clear lens. The IOL was subsequently implanted through the main incision using the BLUEMIXS 180 injector (Carl Zeiss meditec, Jena, Germany) for trifocal IOL , VISCOJECTTM BIO injector for toric trifocal IOL and then the OVD was removed. Postoperative pharmacologic treatment is performed with the combination of antibiotic and steroidal anti-inflammatory drops<br>* Other names: Zeiss Meditec;|
| Active Comparator: Toric Trifocal IOL RELEX SMILE<br>Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group) | Procedure: Toric Trifocal IOL<br>* Interventions are performed using a standard technique of sutureless phacoemulsification. In all cases, topical anesthesia was administered and pharmacologic mydriasis was induced using a combination of tropicamide and phenylephrine (10.0%). A mean clear corneal microincision of 2.2 mm was made with a knife according to position of the preop highest K value of the patient. A paracentesis was made 60 degree to 80 degree, clockwise from the main incision, and the anterior chamber was filled with an ophthalmic viscoelastic (OVD) after phacoemulsification/lensectomy and removal of clear lens. The IOL was subsequently implanted through the main incision using the BLUEMIXS 180 injector (Carl Zeiss meditec, Jena, Germany) for trifocal IOL , VISCOJECTTM BIO injector for toric trifocal IOL and then the OVD was removed. Postoperative pharmacologic treatment is performed with the combination of antibiotic and steroidal anti-inflammatory drops<br>* Other names: Zeiss Meditec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of visual and refractive outcome after Toric Trifocal lens implantation | Complete ocular examination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL | Complete ocular examination | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RELEX SMILE, Trifocal IOL, Toric Trifocal IOL