Corneal Dystrophy, Epithelial Basement Membrane
Conditions
Brief 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.
Interventions
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
Sponsors
BioTissue Holdings, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with significant EBMD that are contemplating cataract surgery. 2. Age range: 50 years and older. 3. Both Genders and all ethnic groups comparable with the local community. 4. Subjects able to understand and willing to sign a written informed consent. 5. Subjects able and willing to cooperate with the investigational plan. 6. Subjects able and willing to complete postoperative follow-up.
Exclusion criteria
1. Subjects with known intolerance to PKS or known allergy to its preservative media. 2. Subjects with symblepharon or lid abnormality preventing PKS placement. 3. Ocular infection within 14 days prior to study entry. 4. Previous ocular surgery or injury within 3 months before enrollment. 5. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis. 6. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Lens Calculation | Change from Baseline to 1 month | Assessed by corneal topography |
| Change in Intraocular Lens Power Calculation | Change from Baseline to 1 month | Assessed using biometry and calculated using Holladay I formula |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study prospective arm receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD | 9 |
| Control Retrospective review of debridement without cryopreserved amniotic membrane | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Study | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 74 years STANDARD_DEVIATION 7.5 | 66.5 years STANDARD_DEVIATION 5.9 | 70 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Intraocular Lens Calculation
Assessed by corneal topography
Time frame: Change from Baseline to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Change in Intraocular Lens Calculation | 1.56 D | Standard Deviation 1.6 |
| Control | Change in Intraocular Lens Calculation | 0.94 D | Standard Deviation 0.7 |
Primary
Change in Intraocular Lens Power Calculation
Assessed using biometry and calculated using Holladay I formula
Time frame: Change from Baseline to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Change in Intraocular Lens Power Calculation | 1.18 D | Standard Deviation 1.2 |
| Control | Change in Intraocular Lens Power Calculation | 0.79 D | Standard Deviation 0.5 |