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CompletedNCT03264534Updated Nov 22, 2023

Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy

An interventional study of limbal relaxing incisions and astigmatic keratotomy in Corneal Astigmatism, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Pre-operative evaluation:

  1. Close examination of the peripheral cornea by slit lamb, particularly in the areas where the incisions will be placed.
  2. Fundus examination to exclude other causes of diminution of vision.
  3. IOP measure.
  4. Precise manifest refraction, uncorrected visual acuity and best corrected visual acuity by snellen's chart.
  5. Standard keratometry to confirm diopters of corneal astigmatism.
  6. 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.

02

Conditions studied

  • Corneal Astigmatism

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03

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    limbal relaxing incisions

    Manually performed limbal relaxing incisions

    Procedure: limbal relaxing incisions

  • Active comparator
    astigmatic keratotomy

    femtosecond laser-guided astigmatic keratotomy

    Procedure: astigmatic keratotomy

Interventions

  • Procedurelimbal relaxing incisions

    Manually performed surgical procedure

  • Procedureastigmatic keratotomy

    femtosecond laser guided surgical procedure

05

What researchers measure

Primary outcomes

  1. Keratometric reading

    measured by Corneal Tomography (Pentacam)

    Time frame: 1 week

06

Study locations

1 site
  • Faculty of Medicine, Assiut University
    Assiut, 71111, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided — 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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264534
Lead sponsor
Assiut University
Responsible party
Ashraf Rashwan (Principal Investigator, Assiut University) — Principal investigator
First posted
Aug 29, 2017
Start date
Mar 21, 2018
Primary completion
Jan 15, 2022
Completion
Jan 15, 2022
Last update
Nov 22, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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