Clinical trial NCT04468022: Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment
Official title: Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment With High Astigmatism and Hyperopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism High Both
Pseudophakia
Hyperopia
Keywords: RELEX SMILE
Trifocal IOL
Toric Trifocal IOL
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups divided in 40 eyes
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure of visual and refractive outcome after Toric Trifocal lens implantation
timeFrame: 6 months
Secondary outcomes:
measure: Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL
timeFrame: 6 months
Other outcomes:
measure: UDVA, CDVA, CNVA, Goldmann applanation tonometry
timeFrame: 6 months
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
affiliation: Principal Doctor
name: Faruk Semiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References: