Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile

NCT04712318 | Enrolling By Invitation

• 1 other identifier: EHospitalPristina
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.

Conditions

Pseudophakia; Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Increase of visual acuity

  Increase of visual acuity by reducing residual refractive errors (myopia, hyperopia) using ReLex Smile after Trifocal IOL implantation

  6 months

Study Arms (2)

ReLex Smile surgery

OTHER

The aim of this study is to investigate the effect of Relex Smile surgery to correct the residual refractive errors (myopic and hyperopic) 6 months after Trifocal IOL Implantation. At myopic residual refraction (min -0.75 D) (100eyes) 6 months after Trifocal IOL Implantation we used Relex-Smile surgery for treatment.

Procedure: Relex Smile

ReLex Smile surgery-fresh corneal lenticule implantation

OTHER

At hyperopic residual refraction 30 eyes 6 months after Trifocal IOL Implantation we used fresh corneal myopic lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients with residual hypermetropic refraction using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity.

Procedure: Relex smile with fresh corneal lenticule implantation

Interventions

Relex Smile PROCEDURE

Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was min -0.75D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(ViscotMedster).

ReLex Smile surgery

Relex smile with fresh corneal lenticule implantation PROCEDURE

VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule. The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticular implantation should be performed according to the low K values.

ReLex Smile surgery-fresh corneal lenticule implantation

Eligibility Criteria

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

You may qualify if:

• residual hypermetropic, myopic refraction on pseudophakic patients
• low visual acuity

You may not qualify if:

• active anterior segment pathologic features,
• previous corneal or anterior segment surgery,
• glaucoma,
• retinal detachment

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Pseudophakia; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: Myopic group 100 eyes hyperopic group 30 eyes

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

KO (1)