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

Manually Performed Limbal Relaxing Incisions vs Femtosecond Laser-guided Astigmatic Keratotomy for Correction of Corneal Astigmatism After Phacoemulsification

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03264534
Enrollment
90
Registered
2017-08-29
Start date
2018-03-21
Completion date
2022-01-15
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Astigmatism

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: 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.

Interventions

Manually performed surgical procedure

femtosecond laser guided surgical procedure

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Keratometric reading1 weekmeasured by Corneal Tomography (Pentacam)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026