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

NCT04468022 | Completed

• 1 other identifier: EyeHospitalPristina
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism High Both; Pseudophakia; Hyperopia

Keywords

RELEX SMILE; Trifocal IOL; Toric Trifocal IOL

Outcome Measures

Primary Outcomes (1)

• Measure of visual and refractive outcome after Toric Trifocal lens implantation

  Complete ocular examination

  6 months

Secondary Outcomes (1)

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

  6 months

Other Outcomes (1)

• UDVA, CDVA, CNVA, Goldmann applanation tonometry

  6 months

Study Arms (2)

Toric Trifocal IOL

ACTIVE COMPARATOR

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

Procedure: Toric Trifocal IOL

Toric Trifocal IOL RELEX SMILE

ACTIVE COMPARATOR

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

Procedure: Toric Trifocal IOL

Interventions

Toric Trifocal IOL PROCEDURE

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

Toric Trifocal IOL; Toric Trifocal IOL RELEX SMILE

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• High spherical hypermetropia
• Astigmatismus \>2 D or higher
• Amblyopia
• Strabismus (accomodative esotropia)

You may not qualify if:

• Glaucoma
• Retinal detachment
• Corneal disease
• Macular degeneration
• Advanced Retinopathy

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Pseudophakia; Hyperopia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors; Eye Diseases

Study Officials

• Faruk Semiz, Dr.

  Principal Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology

Model Details: Two groups divided in 40 eyes

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 13, 2020
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 15, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)