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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femtosecond limbal relaxing incision (LRI) | Active Comparator | Eyes will be treated with arcuate incisions from a femtosecond laser system. |
|
| Manual LRI | Active Comparator | Eyes will be treated with arcuate incisions completed manually with a blade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| femtosecond laser system arcuate corneal incision | Device | Corneal arcuate incision made either with a blade (manual) or femtosecond laser system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Refractive Astigmatism | Residual refractive astigmatism measured in diopters | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) | The number of eyes with residual refractive astigmatism < 0.50 diopters (D) | 3 months |
| Uncorrected Monocular Distance Visual Acuity |
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Inclusion Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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| Name | Affiliation | Role |
|---|---|---|
| Clayton G Blehm, MD | Gainesville Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Eye Associates | Gainesville | Georgia | 30501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Femtosecond Limbal Relaxing Incision (LRI) | Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system. |
| FG001 | Manual LRI | Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only subjects who completed the study are included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Corneal arcuate incision made either with a blade (manual) or femtosecond laser system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only subjects completing the study were included in the baseline analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Residual Refractive Astigmatism | Residual refractive astigmatism measured in diopters | Posted | Mean | Standard Deviation | diopters | 3 months | Eyes | Eyes |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Femtosecond Limbal Relaxing Incision (LRI) | Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Full thickness perforation | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm, MD | Gainesville Eye Associates | 7705324444 | claytonblehm@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2019 | Jul 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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Contralateral eye study
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|
| Manual LRI | Other | Manual LRI |
|
Uncorrected monocular distance visual acuity in logMAR
| 3 months |
| Spherical Equivalent Refraction | Spherical equivalent refraction in diopters | 3 months |
| Corneal Astigmatism | Anterior corneal astigmatism | 3 months |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Only subjects completing the study were included in the baseline analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Only subjects completing the study were included in the analysis population. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
|
| Secondary | Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) | The number of eyes with residual refractive astigmatism < 0.50 diopters (D) | Posted | Count of Units | Eyes | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Uncorrected Monocular Distance Visual Acuity | Uncorrected monocular distance visual acuity in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Spherical Equivalent Refraction | Spherical equivalent refraction in diopters | Posted | Mean | Standard Deviation | diopters | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Corneal Astigmatism | Anterior corneal astigmatism | Posted | Mean | Standard Deviation | diopters | 3 months | Eyes | Eyes |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Manual LRI | Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI | 0 | 41 | 0 | 41 | 2 | 41 |
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