N/A
Completed N=40
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Corneal Wound Healing
Source: ClinicalTrials.gov NCT00915759 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Number of Days to Complete Re-epithelialization — 4.6; 4.1 days to complete re-epithelialization
Summary
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days to Complete Re-epithelialization |
4.0; 3.8 | — |
| SECONDARY Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) |
4.6; 4.8 | — |
| SECONDARY Number of Eyes With Complications/Adverse Events |
1; 0; 1; 0; 2; 0 | — |
| SECONDARY Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively |
34; 35 | — |
| SECONDARY Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively |
32; 30 | — |
| SECONDARY Number of Eyes With Clinically Significant Corneal Haze |
0; 0 | — |
| SECONDARY Tear Total Protein Levels |
9.6; 9.9 | — |
Eligibility Criteria
Inclusion Criteria
- Active duty US Army Soldiers eligible for care at WRAMC.
- Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements.
Exclusion Criteria
- Any reason to be excluded for PRK.
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Anterior basement membrane dystrophy.
- History of recurrent epithelial erosion.
- Significant dry eye (symptomatic with Schirmer test < 5 mm at 5 minutes).
- Other corneal epithelial disorder or healing abnormality.
- Patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., ProKera) between the eyelid and globe.
Data sourced from ClinicalTrials.gov (NCT00915759). 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.