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

Eye Hospital Pristina Kosovo

Status: Invitation-only

Conditions: Myopia; Pseudophakia; Hyperopia

Treatments: Procedure: Relex smile with fresh corneal lenticule implantation; Procedure: Relex Smile

Study type: Interventional

Funder types: Other

Identifiers

NCT04712318

EHospitalPristina

Details and patient eligibility

About

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

Full 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

Enrollment: 130 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

ReLex Smile surgery

Other group

Description:

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.

Treatment:

Procedure: Relex Smile

ReLex Smile surgery-fresh corneal lenticule implantation

Other group

Description:

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.

Treatment:

Procedure: Relex smile with fresh corneal lenticule implantation