Incisional Correction of Corneal Astigmatism During Phacoemulsification

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Procedure: opposite clear corneal incisions (OCCI)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • Bab-Almuadham
    • Baghdad, Bab-Almuadham, Iraq, 12221
      • Ghazi al-Hariri Surgical Specialties Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control (CCI Group); The Participants will undergo phacoemulsification with on-axis incision	Procedure: opposite clear corneal incisions (OCCI); Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique. In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision.
Active Comparator: Study (OCCI Group); The Participants will undergo phacoemulsification with opposite clear corneal incisions	Procedure: opposite clear corneal incisions (OCCI); Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique. In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity	Uncorrected visual acuity and best corrected visual acuity after the surgery	After 1 month of surgery

Collaborators and Investigators

• Sponsor: Al-Rasheed University College
• Collaborators: Baghdad Medical City

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: AR200105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No