N/A
Completed N=20
Optimizing the Ocular Surface Prior to Cataract Surgery
Corneal Dystrophy, Epithelial Basement Membrane
Source: ClinicalTrials.gov NCT02766907 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Change in Intraocular Lens Calculation — 1.56; 0.94 D
Summary
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Lens Calculation |
1.56; 0.94 | — |
| PRIMARY Change in Intraocular Lens Power Calculation |
1.18; 0.79 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with significant EBMD that are contemplating cataract surgery.
- Age range: 50 years and older.
- Both Genders and all ethnic groups comparable with the local community.
- Subjects able to understand and willing to sign a written informed consent.
- Subjects able and willing to cooperate with the investigational plan.
- Subjects able and willing to complete postoperative follow-up.
Exclusion Criteria
- Subjects with known intolerance to PKS or known allergy to its preservative media.
- Subjects with symblepharon or lid abnormality preventing PKS placement.
- Ocular infection within 14 days prior to study entry.
- Previous ocular surgery or injury within 3 months before enrollment.
- Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
- Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Data sourced from ClinicalTrials.gov (NCT02766907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.