Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Eye Hospital Pristina Kosovo

Status: Invitation-only

Conditions: Macular Corneal Dystrophy

Treatments: Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04642729

EyeHP

Details and patient eligibility

About

The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.

Full description

Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment.

Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency.

According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• indications for penetrating keratoplasty
• low transparec of corneae
• low visual acuity

Exclusion criteria

• active anterior segment pathology
• previous corneal or anterior segment surgery
• any infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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15 participants in 2 patient groups

ReLex Smile surgery

Other group

Description:

The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser.

Treatment:

Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery

fresh corneal lenticule implantation

Other group

Description:

Using VisuMax Femtosecond Laser we make intrastromal pocket incision 2-3 mm in periphery of cornea (Because the macular dystrophy is in the center more progressive) and 150 µm deep to put fresh corneal lenticule. After one month using VisuMax we create a flap using autologous serum with purpose to remove more dead keratocytes and adding live keratocytes with aim to regenerate the metabolism of cornea.

Treatment:

Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery