An interventional study of Toric Trifocal IOL in Astigmatism High Both, Pseudophakia and Hyperopia, sponsored by Eye Hospital Pristina Kosovo. Completed at 1 site in Kosovo. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and 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.
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.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 25 interventional studies indexed under Pseudophakia.
Browse Pseudophakia studies →Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Twenty patients (20) underwent Toric Trifocal IOL surgery (first group)
Procedure: Toric Trifocal IOL
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
Also known as: Zeiss Meditec
Measure of visual and refractive outcome after Toric Trifocal lens implantation
Complete ocular examination
Time frame: 6 months
Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL
Complete ocular examination
Time frame: 6 months
UDVA, CDVA, CNVA, Goldmann applanation tonometry
Examinations used
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Jun 2019, 12 months.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Eye Hospital Pristina Kosovo