Pterygium of Right Eye, Pterygium of Left Eye, Pterygium of Both Eyes, Pterygium
Conditions
Keywords
Pterygium,, Mini-SLET, Conjunctival-Limbal autograft
Brief summary
The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
Detailed description
The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
Interventions
PROCEDUREPterygium Excision
Pterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The allocation of the study participants will be concealed in opaque envelopes.
Intervention model description
The allocation sequence will be generated by an investigator and will
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary nasal pterygium \> 2mm * Patients who can present and continue follow-up for the duration of the study * Acceptance to participate in the study by signing the informed consent.
Exclusion criteria
* Patients with rheumatoid arthritis * Collagenopathy * Pregnant * Infection, conjunctival inflammation or ocular trauma * Glaucoma * Previous ocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 1 month, 3, months, 6 months and 12 months after surgery. | Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative symptoms | 1 month, 3, months, 6 months and 12 months after surgery. | Any postoperative symptoms, such as: pain, foreign body sensation, irritation, and tearing. |
Countries
Mexico
Contacts
Primary ContactEnrique Graue Hernandez
Backup ContactNicolas Kahuam Lopez
Outcome results
None listed