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

Adenoviral Keratoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05123014
• Other study ID #: EyeHPristina 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 1, 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

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoviral Keratoconjunctivitis
• Keratitis
• Keratoconjunctivitis

Intervention

Other:
• relex smile
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.

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	Increasing corneal transparency	Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.	12 months
Secondary	Increase of visual acuity	Upon implanting fresh corneal lenticule according to clarity of cornea, uncorrected vision increased.	12 months