Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease

Eye Hospital Pristina Kosovo

Status: Active, not recruiting

Conditions: Adenoviral Keratoconjunctivitis

Treatments: Other: relex smile

Study type: Interventional

Funder types: Other

Identifiers

NCT05123014

EyeHPristina 1

Details and patient eligibility

About

Adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. Most of these infections have symptoms like (Ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.Adenoviral subepithelial infiltration is one of the most difficult complication to treat. Our purpose is to evaluate corneal transparency, recurrence, and visual acuity in patients with adenoviral subepithelial infiltration by first removing the infiltrative stroma with a smile and implanting the same volume of fresh lenticule in the prepared stromal pocket.

Full description

Our treatment of adenoviral keratitis using lenticule implantation and autologus serum it has been applied to patients who have received medical treatment(Antiviral medications, topical corticosteroids ,compresses, artificial tears, and topical cycloplegic) for a long time but have not been successful.

In OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume. AS-OCT was evaluated using corneal topography and glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were recorded during the follow-up period.

The patients were followed for one year. No complications were observed in the patients. After the operation, there was an increase in satisfaction and vision. They returned to their daily lives very quickly.

Postoperatively, uncorrected vision increased to 6 lines in 12 eyes, seven lines in 11 eyes, and eight lines in 3 eyes.

Enrollment: 45 patients

Sex: All

Ages: 24 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• low transparency of cornea
• low visual acuity
• recurrence keratitis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

ReLex Smile surgery

Other group

Description:

Fresh Corneal Lenticule Implantation using Relex-Smile Surgery We used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). 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 adenoviral keratitis.

Treatment:

Other: relex smile