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Not Yet RecruitingNCT06896357

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

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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 .

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELimbal relaxing incisionsA 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.

Timeline

Start date
2025-05-01
Primary completion
2026-05-01
Completion
2026-06-01
First posted
2025-03-26
Last updated
2025-03-26

Source: ClinicalTrials.gov record NCT06896357. Inclusion in this directory is not an endorsement.