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

Primary Purpose

Adenoviral Keratoconjunctivitis

Status
Active
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
relex smile
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoviral Keratoconjunctivitis

Eligibility Criteria

24 Years - 43 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ReLex Smile surgery

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Increase of visual acuity
Upon implanting fresh corneal lenticule according to clarity of cornea, uncorrected vision increased.

Full Information

First Posted
November 5, 2021
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT05123014
Brief Title
Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Official Title
Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoviral Keratoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
LENTICULE IMPLANTATION AND AUTOLOGOUS SERUM NEW APPROACH IN TREATMENT OF ADENOVIRAL KERATITIS DISEASE
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReLex Smile surgery
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
relex smile
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increasing corneal transparency
Description
Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Increase of visual acuity
Description
Upon implanting fresh corneal lenticule according to clarity of cornea, uncorrected vision increased.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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