Incisional Correction of Corneal Astigmatism During Phacoemulsification

Phase 4

Completed

• Conditions: Astigmatism
• Interventions: Procedure: opposite clear corneal incisions (OCCI)

• 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

Arm && Interventions

Group	Intervention	Description
Study (OCCI Group)	opposite clear corneal incisions (OCCI)	The Participants will undergo phacoemulsification with opposite clear corneal incisions
Control (CCI Group)	opposite clear corneal incisions (OCCI)	The Participants will undergo phacoemulsification with on-axis incision

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