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

Eye Hospital Pristina Kosovo

Status: Completed

Conditions: Astigmatism High Both; Pseudophakia; Hyperopia

Treatments: Procedure: Toric Trifocal IOL

Study type: Interventional

Funder types: Other

Identifiers

NCT04468022

EyeHospitalPristina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. High spherical hypermetropia
2. Astigmatismus >2 D or higher
3. Amblyopia
4. Strabismus (accomodative esotropia)

Exclusion criteria

1. Glaucoma
2. Retinal detachment
3. Corneal disease
4. Macular degeneration
5. Advanced Retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Toric Trifocal IOL

Active Comparator group

Description:

Twenty patients (20) underwent Toric Trifocal IOL surgery (first group)

Treatment:

Procedure: Toric Trifocal IOL

Toric Trifocal IOL RELEX SMILE

Active Comparator group

Description:

Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group)

Treatment:

Procedure: Toric Trifocal IOL