Incisional Correction of Corneal Astigmatism During Phacoemulsification

Phase 4

Completed

• Conditions: Astigmatism

• Registration Number: NCT04418986
• Lead Sponsor: Al-Rasheed University College

Brief Summary

Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.

It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-05
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clear cornea
• No history of previous ocular surgery
• Central corneal thickness (CCT) <640

Exclusion Criteria

• Irregular corneal astigmatism or lenticular astigmatism
• Corneal opacities or pathology like Fuch's endothelial dystrophy
• Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
• Posterior segment diseases and pathology
• Complicated phacoemulsification

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean surgically induced astigmatism	After 1 month of surgery	Mean surgically induced astigmatism, measured by a vector-corrected method
Mean astigmatic correction	After 1 month of surgery	Astigmatic correction change after the correction surgery

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity	After 1 month of surgery	Uncorrected visual acuity and best corrected visual acuity after the surgery

Trial Locations

Locations (1)

Ghazi al-Hariri Surgical Specialties Hospital; 🇮🇶 Baghdad, Bab-Almuadham, Iraq