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

Not Applicable

• Conditions: Hyperopia; Pseudophakia; Myopia
• Interventions: Procedure: Relex Smile; Procedure: Relex smile with fresh corneal lenticule implantation

• Registration Number: NCT04712318
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief Summary

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

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 Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-06-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReLex Smile surgery	Relex Smile	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.
ReLex Smile surgery-fresh corneal lenticule implantation	Relex smile with 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.

Primary Outcome Measures

Name	Time	Method
Increase of visual acuity	6 months	Increase of visual acuity by reducing residual refractive errors (myopia, hyperopia) using ReLex Smile after Trifocal IOL implantation

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo