Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy
Primary Purpose
Corneal Astigmatism
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
limbal relaxing incisions
astigmatic keratotomy
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Astigmatism
Eligibility Criteria
Inclusion Criteria:
- patients who have undergo phacoemulsification.
- Clear cornea.
- Astigmatism from 1 diopter up to 4 diopters
Exclusion Criteria:
- corneal opacity.
- History of corneal surgery.
- Thin cornea.
- Other cause of diminution of vision rather than corneal astigmatism (eg: optic disc atrophy & maculopathy).
- Astigmatism less than 1 diopter and more than 4 diopters.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
limbal relaxing incisions
astigmatic keratotomy
Arm Description
Manually performed limbal relaxing incisions
femtosecond laser-guided astigmatic keratotomy
Outcomes
Primary Outcome Measures
Keratometric reading
measured by Corneal Tomography (Pentacam)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03264534
Brief Title
Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy
Official Title
Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy for Correction of Corneal Astigmatism After Phacoemulsification
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Astigmatic keratotomy (AK) is used to treat numerous refractive disorders, including congenital astigmatism, residual corneal astigmatism at the time of or following cataract surgery, post-traumatic astigmatism, and astigmatism after corneal transplantation.
Within the past few years, much consideration has been given to an evolutionary variant of the procedure, the limbal relaxing incision (LRI). By moving the incision farther to the periphery, cataract surgeons can safely and predictably remediate mild to moderate amounts of regular astigmatism at the time of cataract surgery by performing this incisional technique.
Recent technological developments have shifted ophthalmologist's attention from manually created LRIs and astigmatic keratotomy procedures to femtosecond laser-guided procedures. Femtosecond lasers offer superior incisional accuracy and reproducibility coupled with minimal effects on collateral tissues, achieving levels of safety and reproducibility exceeding those of mechanical techniques. A major clinical application of the femtosecond laser is for creating arcuate incisions that have a precise and accurate length, depth, angular position, and optical zone.
Detailed Description
Pre-operative evaluation:
Close examination of the peripheral cornea by slit lamb, particularly in the areas where the incisions will be placed.
Fundus examination to exclude other causes of diminution of vision.
IOP measure.
Precise manifest refraction, uncorrected visual acuity and best corrected visual acuity by snellen's chart.
Standard keratometry to confirm diopters of corneal astigmatism.
Corneal Tomography (Pentacam).
Surgical procedures:
LRIs are performed using topical anesthesia. Patients are instructed to fixate on the microscope light. Before surgery, the steep meridian was identified with a marker dyed with methylene blue with the patient sitting up right. A diamond knife is set at a depth of 0.600 mm to 0.650 mm based on the peripheral pachymetric readings over the area of intended incision. The goal was a maximum reduction in astigmatism without overcorrection in with-the rule cases and with little overcorrection in against the rule cases. In the case of an overcorrection, the LRI can be sutured without creating any irregular astigmatism.
Performing femtosecond laser-guided astigmatic keratotomy requires the parameters of length, position, depth and distance from the visual axis where the incisions will be created. The depth of our incisions is 85% of the corneal pachymetry in the area of the incision. We have set our distance from the visual axis at 8 mm. This information is all downloaded onto the femtosecond laser. Then, we begin the surgical procedure by docking the laser onto the cornea. An overlay of the incisions is then visible on the surgical screen. After treatment, we bring the patient to the operating microscope and open the incisions with a Sinskey hook. By using low energy, the incisions do not have significant effect until they are opened.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
limbal relaxing incisions
Arm Type
Active Comparator
Arm Description
Manually performed limbal relaxing incisions
Arm Title
astigmatic keratotomy
Arm Type
Active Comparator
Arm Description
femtosecond laser-guided astigmatic keratotomy
Intervention Type
Procedure
Intervention Name(s)
limbal relaxing incisions
Intervention Description
Manually performed surgical procedure
Intervention Type
Procedure
Intervention Name(s)
astigmatic keratotomy
Intervention Description
femtosecond laser guided surgical procedure
Primary Outcome Measure Information:
Title
Keratometric reading
Description
measured by Corneal Tomography (Pentacam)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who have undergo phacoemulsification.
Clear cornea.
Astigmatism from 1 diopter up to 4 diopters
Exclusion Criteria:
corneal opacity.
History of corneal surgery.
Thin cornea.
Other cause of diminution of vision rather than corneal astigmatism (eg: optic disc atrophy & maculopathy).
Astigmatism less than 1 diopter and more than 4 diopters.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is a possibility of using these data in another related study so i am not sure about the time of sharing the individual participant data
Learn more about this trial
Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy
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