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Treatment of ligneous conjunctivitis with platelet-rich plasma

Use of Platelet-enriched allogeneic serum eye drops as an adjuvant for the treatment of recurrent Ligneous conjunctivitis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-83cj4wn
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasminogen

Interventions

This is an interventional case series study, non-randomized, with a single arm, totaling 3 patients being treated.The patient will be offered the possibility of undergoing surgical excision of ocular

Sponsors

Universidade Federal de São Paulo - UNIFESP/EPM
Lead Sponsor
Universidade Federal de São Paulo - UNIFESP/EPM
Collaborator

Eligibility

Age
2 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with ligneous conjunctivitis with chronic ocular involvement (more than 1 year of disease) who do not respond to clinical treatment and present recurrence of pseudomembranes after simple resection or after attempted clinical treatment. Age from 2 years. Availability to attend all study visits and adequately follow all post-operative guidelines and care. Understanding of the study, stages and follow-up, and agreement expressed by signing the consent form (by the patient or guardian) and assent form (when applicable). Stable clinical condition and no change in topical medications or systemic anti-inflammatory drugs in the 60 days prior to and during the study. Carry out a complete pre-operative assessment, including general and specific complementary exams as clinically indicated and pre-anesthetic assessment

Exclusion criteria

Exclusion criteria: Eye surgery in the last 6 months. Patients with a previous history of hypersensitivity to any of the products used to treat ligneous conjunctivitis included in this protocol. Pregnant or breastfeeding women. Active eye infection. History of herpetic keratitis. Use of contact lenses within 48 hours of the start of the study, or during the study. Glaucoma. Presence of any other serious ocular change that indicates the need to perform another ophthalmological procedure more urgently, such as retinal detachment or ocular perforation. Contraindication to carrying out the procedure by the anesthesiology team

Design outcomes

Primary

MeasureTime frame
The primary outcome evaluated will be the observation of recurrence until the end of postoperative follow-up

Secondary

MeasureTime frame
Increase in visual acuity ;Reduction in staining pattern with 1% sodium fluorescein and 1% lysamine green using anterior biomicroscopy imaging ;Improvement in eyelid anatomy and function of blinking using MDR1 and ptosis measure ;Improving patient quality of life using quality of life questionnaire

Countries

Brazil

Contacts

Public ContactÍtalo Oliveira

Universidade Federal de São Paulo - UNIFESP/EPM

italopo@yahoo.com.br+55(11)5089-9200

Outcome results

None listed

Source: REBEC (via WHO ICTRP)