Recurrent Pterygium
Conditions
Keywords
recurrent pterygium, bevacizumab, triple dose
Brief summary
Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF agents have been recently proposed as primary treatments, such as perioperative adjuvants, as well as treatments for pterygia recurrences after surgery. The aim of the present study was to prospectively evaluate the effect of three subconjunctival bevacizumab injections in patients with an early pterygium recurrence. Materials and Methods: The current study was a non-randomized single central trial. The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.
Detailed description
The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.
Interventions
DRUGBevacizumab
DRUGMedical Treatment
Care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks.
PROCEDUREArgon laser treatment
Sponsors
National Council of Science and Technology, Mexico
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included
Exclusion criteria
* Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women. Patients with diabetes Mellitus and colagenopathies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pterygium recurrence | One year | Evidence of vessel growth on both, corneal and conjunctival area after bevacizumab treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pterygia measurements | One year | Measurements were performed according to Welch et al. modified technique as following: the distance in millimeters from the limbus to the apex of the lesion on the cornea (horizontal length) was performed using the slit-lamp beam (BQ 900, Haag-Streit, Koeniz, Switzerland). A standard magnification of 16 was used and the variable aperture was focused from the limbus to the apex. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptoms evaluation | One year | The frequency of symptoms (redness, watery eyes, itching, burning, foreign body sensation, and fluctuating vision) were evaluated according to Nava-Castañeda et al Questionnaire (2003). Symptoms were graded as follows: 0, never; 1, rarely (once a week); 2, occasionally (several times a week); 3, frequently (once a day); 4, usually (several times a day); and 5, continually (every hour of the day). In addition, the severity of these signs/sympots were scored at each visit on a scale of 0 to 3, with 0 representing the absence of the symptom, 1 mild, 2 moderate, and 3 severe. A total symptoms score, which is a measure of the overall severity of the patients,s conjunctival condition, was calculated by multiplying (for each individual symptom/condition) the numerical values corresponding to frequency and severity, and then adding the products for all symptoms. |
Countries
Mexico
Outcome results
None listed