Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07307820
Eligibility Criteria:
Inclusion Criteria Age 18 to 65 years (both sexes). Diagnosis of bilateral primary nasal pterygium requiring surgical excision (both eyes affected).
Horizontal corneal encroachment of the pterygium ≥ 2.0 mm in each eye. Lesions amenable to conjunctival autograft coverage with expected graft size obtainable from superior bulbar conjunctiva.
Willingness and ability to attend scheduled follow-up visits for 1 month postoperatively.
Able to provide written informed consent.
Exclusion Criteria Recurrent pterygium in either eye. Previous ocular surgery on the study eye(s) (including prior pterygium surgery) or conjunctival grafting.
Active ocular surface disease or infection (e.g., conjunctivitis, keratitis) at screening.
Severe dry eye disease (e.g., Schirmer's test ≤ 5 mm or TBUT \< 5 s) likely to affect healing.
Significant ocular comorbidities affecting wound healing or outcome interpretation: uncontrolled glaucoma with conjunctival filtering surgery, ocular surface cicatrizing disorders (e.g., ocular pemphigoid), severe blepharitis, or severe meibomian gland dysfunction.
Systemic conditions that impair wound healing or increase surgical risk (e.g., uncontrolled diabetes mellitus with HbA1c \> 8.0%, connective tissue disorders, immunosuppression, chronic systemic corticosteroid use).
Current use of anticoagulant therapy that cannot be safely paused per local perioperative protocol (if this precludes safe graft fixation).
Pregnancy or breastfeeding. Known allergy to any material used in the procedure or postoperative medications.
Inability to comply with follow-up schedule or provide informed consent (e.g., cognitive impairment, planning to move away).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT07307820
Study Brief:
Protocol Section:
NCT07307820