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

NCT05123014 | Active Not Recruiting

• 1 other identifier: EyeHPristina 1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoviral Keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Increasing corneal transparency

  Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.

  12 months

Secondary Outcomes (1)

• Increase of visual acuity

  12 months

Study Arms (1)

ReLex Smile surgery

OTHER

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.

Other: relex smile

Interventions

relex smile OTHER

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.

ReLex Smile surgery

Eligibility Criteria

• Age: 24 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: LENTICULE IMPLANTATION AND AUTOLOGOUS SERUM NEW APPROACH IN TREATMENT OF ADENOVIRAL KERATITIS DISEASE

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 25, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)