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

NCT03264534 | Completed

• 1 other identifier: 17200119
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Astigmatism

Outcome Measures

Primary Outcomes (1)

• Keratometric reading

  measured by Corneal Tomography (Pentacam)

  1 week

Study Arms (2)

limbal relaxing incisions

ACTIVE COMPARATOR

Manually performed limbal relaxing incisions

Procedure: limbal relaxing incisions

astigmatic keratotomy

ACTIVE COMPARATOR

femtosecond laser-guided astigmatic keratotomy

Procedure: astigmatic keratotomy

Interventions

limbal relaxing incisions PROCEDURE

Manually performed surgical procedure

limbal relaxing incisions

astigmatic keratotomy PROCEDURE

femtosecond laser guided surgical procedure

astigmatic keratotomy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 29, 2017
• Study Start: March 21, 2018
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

EG (1)