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

Sponsor
Eye Hospital Pristina Kosovo (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04712318
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
72
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Relex Smile
  • Procedure: Relex smile with fresh corneal lenticule implantation
N/A

Detailed Description

Residual refractive errors(myopia 50% and hyperopia 30%) are the main problems at patients after IOL Implantation.

The residual refraction (myopic and hyperopic) after IOL Implantation is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition.

Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK).

Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis.

Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment.

The aim of our study is to investigate the effect of Relex-Smile to treat the residual refraction errors (myopia and hypermetropia) 6 months after IOL Implantation.

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. In pseudophakic patients with hyperopic astigmatism and residual refraction ,corneal topography-guided intrastromal fresh lenticular implantation should be performed and the lenticule was placed according to the low K value.

At myopic residual refraction(-0.75D till -5.50D) after IOL Implantation The method used at the EYE Hospital Pristina by ReLex-SMILE is safe and effective method, since there is no flap and this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.

At hyperopic residual refraction this study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant(-1.50D) that will be taken from myopic patients to implant on Pseudophakic patients with residual hypermetropia refraction (+1.0D) using VisuMax Femtosecond laser - Smile module surgery

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Myopic group 100 eyes hyperopic group 30 eyesMyopic group 100 eyes hyperopic group 30 eyes
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Succesful Treatment of Residual Refraction Errors (Myopic and Hyperopic) 6 Months After Trifocal IOL Implantation With Relex-Smile
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Other: ReLex Smile surgery

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
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).

Other: ReLex Smile surgery-fresh corneal lenticule implantation

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
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.

Outcome Measures

Primary Outcome Measures

  1. Increase of visual acuity [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • residual hypermetropic, myopic refraction on pseudophakic patients

  • low visual acuity

Exclusion Criteria:
  • active anterior segment pathologic features,

  • previous corneal or anterior segment surgery,

  • glaucoma,

  • retinal detachment

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Hospital PristinaPristinaKosovo10000

Sponsors and Collaborators

  • Eye Hospital Pristina Kosovo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo
ClinicalTrials.gov Identifier:
NCT04712318
Other Study ID Numbers:
  • EHospitalPristina
First Posted:
Jan 15, 2021
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021