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NCT Number: NCT06896357

Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism

To compare the effect of Limbal relaxing incisions (LRIs) plus spectacle correction versus spectacle correction alone on subjective and objective improvement in visual function for correcting post phacoemulsification high astigmatism .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Astigmatism is one of the commonest refractive errors encountered during our clinical practice. Surgically induced astigmatism is the main obstacle to achieve good uncorrected visual acuity following cataract surgery. It is estimated that corneal astigmatism of more than 1.0 diopter (D) is found in up to 40% of patients presenting for cataract surgery, 1.5D or more is present in over 20% and above 2.0D in 10%.

Astigmatism induces distortion of the image leading to compromise quality of vision. In order to achieve better visual results, the effect of postoperative astigmatism should be minimized, management options for corneal astigmatism include glasses, contact lenses, and surgery such as Limbal relaxing incisions (LRIs), refractive laser surgery, toric lenses or rarely corneal grafting. The LRIs technique involves the placement of incisions corresponding to the steep meridian, resulting in corneal flattening and the reduction of astigmatic power. LRI is a safe and an inexpensive procedure, which is simple for experts to perform. Although most of the nomograms recommended that LRIs technique can correct up to 3 D of astigmatism ,it has been found that it is possible to correct even more than 4 D if the incisions were performed on high degrees of astigmatism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conventional phacoemulsification was done at least one month earlier.
  • Clear cornea with corneal astigmatism more than 3.0 D.

Exclusion criteria

  • History of corneal surgeries (e.g., keratoplasty, refractive surgery, and corneal wound repair).
  • Ocular trauma.
  • Other intraocular surgery.
  • Patient with corneal opacities.
  • Thin cornea .
  • Any significant ocular disease causing diminution of vision (e.g., optic atrophy, diabetic retinopathy, and age-related macular degeneration), autoimmune disease, and peripheral corneal disease.

Treatment and study plan

Limbal relaxing incisions

Procedure

A fixed depth diamond-guarded knife (Gemcision LRI 600 Microns Blade, Katalyst Surgical, chesterfield, MO, USA) will be used to create a paired circumferential corneal incision, following the limbal curvature, 1-1.5mm anterior to the limbus centered on the steep corneal meridian. The incision arc length will be ninety degree according to the Nichamin Age and Pachymetry Adjusted (NAPA) nomogram.

Primary outcomes

  1. visual acuity improvement

    Time frame: 3 months

    assessment the improvement in visual acuity ,which will be measured by Landolt Cs chart with decimal notation.

  2. contrast sensitivity improvement

    Time frame: 3 months

    Assessment the improvement in contrast sensitivity using Pelli-Robson contrast sensitivity test .

Study contacts

Contact information is provided by the study sponsor or research team.

youstina shaheir gad, resident doctor

CONTACT

[email protected]

+2088234-1993

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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