Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

Refractive Errors Clinical Trial

— Relex-Smile  

Official title:

Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04793893
• Other study ID #: EPristinaHospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: November 8, 2025

Study information

• Verified date: February 2024
• Source: Eye Hospital Pristina Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.

Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)

Description:

The main problem at young patients post - LASIK after one year is residual refractive errors.

The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).

1. The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.

2. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: November 8, 2025
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• residual hypermetropic refraction,

• low visual acuity

Exclusion Criteria:

• active anterior segment pathology,

• glaucoma,

• retinae detachment,

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• ReLex Smile
With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).

Locations

Country	Name	City	State
Kosovo	Eye Hospital Pristina	Pristina

Sponsors (1)

Lead Sponsor	Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of visual acuity	Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.	12 months