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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Astigmatism

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients who have undergo phacoemulsification.
  2. Clear cornea.
  3. Astigmatism from 1 diopter up to 4 diopters

Exclusion Criteria:

  1. corneal opacity.
  2. History of corneal surgery.
  3. Thin cornea.
  4. Other cause of diminution of vision rather than corneal astigmatism (eg: optic disc atrophy & maculopathy).
  5. 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

    First Posted
    August 24, 2017
    Last Updated
    January 9, 2018
    Sponsor
    Assiut University
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    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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