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

Primary Purpose

Astigmatism High Both, Pseudophakia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Toric Trifocal IOL
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism High Both focused on measuring RELEX SMILE, Trifocal IOL, Toric Trifocal IOL

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Toric Trifocal IOL

Toric Trifocal IOL RELEX SMILE

Arm Description

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

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

Outcomes

Primary Outcome Measures

Measure of visual and refractive outcome after Toric Trifocal lens implantation
Complete ocular examination

Secondary Outcome Measures

Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL
Complete ocular examination

Full Information

First Posted
June 29, 2020
Last Updated
August 29, 2021
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04468022
Brief Title
Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment
Official Title
Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment With High Astigmatism and Hyperopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism High Both, Pseudophakia, Hyperopia
Keywords
RELEX SMILE, Trifocal IOL, Toric Trifocal IOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups divided in 40 eyes
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toric Trifocal IOL
Arm Type
Active Comparator
Arm Description
Twenty patients (20) underwent Toric Trifocal IOL surgery (first group)
Arm Title
Toric Trifocal IOL RELEX SMILE
Arm Type
Active Comparator
Arm Description
Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group)
Intervention Type
Procedure
Intervention Name(s)
Toric Trifocal IOL
Other Intervention Name(s)
Zeiss Meditec
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure of visual and refractive outcome after Toric Trifocal lens implantation
Description
Complete ocular examination
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL
Description
Complete ocular examination
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
UDVA, CDVA, CNVA, Goldmann applanation tonometry
Description
Examinations used
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faruk Semiz, Dr.
Organizational Affiliation
Principal Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
No

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

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