Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment
- Conditions
- Astigmatism High BothPseudophakiaHyperopia
- Interventions
- Procedure: Toric Trifocal IOL
- Registration Number
- NCT04468022
- Lead Sponsor
- Eye Hospital Pristina Kosovo
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- High spherical hypermetropia
- Astigmatismus >2 D or higher
- Amblyopia
- Strabismus (accomodative esotropia)
- Glaucoma
- Retinal detachment
- Corneal disease
- Macular degeneration
- Advanced Retinopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Toric Trifocal IOL Toric Trifocal IOL Twenty patients (20) underwent Toric Trifocal IOL surgery (first group) Toric Trifocal IOL RELEX SMILE Toric Trifocal IOL Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group)
- Primary Outcome Measures
Name Time Method Measure of visual and refractive outcome after Toric Trifocal lens implantation 6 months Complete ocular examination
- Secondary Outcome Measures
Name Time Method Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL 6 months Complete ocular examination
Trial Locations
- Locations (1)
Eye Hospital Pristina
Pristina, Kosovo