Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment
Condition: Astigmatism High Both; Pseudophakia; Hyperopia
MeSH terms: Astigmatism; Hyperopia; Pseudophakia
Study type: Interventional

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.
    

Intervention name(s): Toric Trifocal IOL
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Zeiss Meditec
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups divided in 40 eyes
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: RELEX SMILE; Trifocal IOL; Toric Trifocal IOL