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NCT Number: NCT04468022

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

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.

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Key information

Conditions

Astigmatism High Both Eye Diseases Hyperopia Pathological Conditions, Signs and Symptoms Pseudophakia Refractive Errors Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital Pristina

Pristina, 10000, Kosovo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toric Trifocal IOL

Procedure

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

Other names: Zeiss Meditec

Primary outcomes

  1. Measure of visual and refractive outcome after Toric Trifocal lens implantation

    Time frame: 6 months

    Complete ocular examination

Secondary outcomes

  1. Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL

    Time frame: 6 months

    Complete ocular examination

Other outcomes

  1. UDVA, CDVA, CNVA, Goldmann applanation tonometry

    Time frame: 6 months

    Examinations used

Sponsors and collaborators

Lead sponsor

Eye Hospital Pristina Kosovo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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