Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relex-Smile.
- Who it may be relevant to
- Registry conditions: Stromal Keratitis. Basic parameters: 21 years — 46 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kosovo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.
Detailed description
Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.
In our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.
Stromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.
Interventions
- Other Relex-Smile
Primary outcome measures
- Corneal transparency [Time frame: 12 months]
Secondary outcome measures (1)
- Evaluation of visual acuity [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- low transparenc of cornea
- low visual acuity
- recurrence of herpetic stromal keratitis
Exclusion criteria
- previous corneal or anterior segment surgery
- any infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kosovo · 1 center
- Eye Hospital Pristina — Pristina
Identifiers
NCT: NCT05156151 · EyehospitalPrishtina