Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04468022 |
| Other study ID # |
EyeHospitalPristina |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
June 15, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Eye Hospital Pristina Kosovo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
