Using amniotic membrane in surgery for blocked tear ducts
Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction
This study is testing if using amniotic membranes during surgery for blocked tear ducts can help adults heal better and have fewer complications.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06226181 on ClinicalTrials.gov |
What this trial studies
This study compares the success rates of external dacryocystorhinostomy performed with and without the application of amniotic membranes in patients suffering from nasolacrimal duct obstruction. The research aims to determine if the use of amniotic membranes can reduce inflammation and improve surgical outcomes by promoting healing and minimizing scarring. Eligible participants are adults over 18 who can undergo general anesthesia and are willing to follow up post-surgery. The study is conducted at the Instituto de Oftalmología Fundación Conde de Valenciana in Mexico City.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with nasolacrimal duct obstruction who can undergo general anesthesia.
Not a fit: Patients with ocular surface diseases, eyelid malpositions, or systemic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of dacryocystorhinostomy, leading to better outcomes for patients with blocked tear ducts.
How similar studies have performed: While the use of amniotic membranes in ophthalmology has shown promise in other contexts, this specific application in dacryocystorhinostomy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * Diagnosis of Nasolacrimal Duct Obstruction or Score ≥ 2 on the Munk Scale * Patients able to undergo general anesthesia * Patients able to keep follow-up * Patients willing to participate in the study and signed informed consent Exclusion Criteria: * Patients with ocular surface diseases that affect surgical outcomes, such as blepharitis, lacrimal punctum epithelization, kissing punctae, facial nerve palsy, allergic conjunctivitis, etc * Patients with eyelid malpositions * Patients diagnosed with systemic inflammatory diseases, such as granulomatosis with polyangiitis, sarcoidosis, etc * Previous history of facial trauma with nasal bone fractures * Pregnancy and lactation
Where this trial is running
Mexico City
- Institiuto de Oftalmología Fundación Conde de Valenciana — Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Yonathan Garfias, MD, PhD
- Email: yogarfias@institutodeoftalmologia.org
- Phone: +52(55)54421700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.