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

Sponsor
Eye Hospital Pristina Kosovo (Other)
Overall Status
Completed
CT.gov ID
NCT04468022
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24.5
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Toric Trifocal IOL
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups divided in 40 eyesTwo groups divided in 40 eyes
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment With High Astigmatism and Hyperopia
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Toric Trifocal IOL

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

Procedure: Toric Trifocal IOL
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
  • Active Comparator: Toric Trifocal IOL RELEX SMILE

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

    Procedure: Toric Trifocal IOL
    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
  • Outcome Measures

    Primary Outcome Measures

    1. Measure of visual and refractive outcome after Toric Trifocal lens implantation [6 months]

      Complete ocular examination

    Secondary Outcome Measures

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

      Complete ocular examination

    Other Outcome Measures

    1. UDVA, CDVA, CNVA, Goldmann applanation tonometry [6 months]

      Examinations used

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Eye Hospital PristinaPristinaKosovo10000

    Sponsors and Collaborators

    • Eye Hospital Pristina Kosovo

    Investigators

    • Principal Investigator: Faruk Semiz, Dr., Principal Doctor

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Faruk Semiz, Head of Ophthalmology, Eye Hospital Pristina Kosovo
    ClinicalTrials.gov Identifier:
    NCT04468022
    Other Study ID Numbers:
    • EyeHospitalPristina
    First Posted:
    Jul 13, 2020
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Faruk Semiz, Head of Ophthalmology, Eye Hospital Pristina Kosovo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 2, 2021