Incisional Correction of Corneal Astigmatism During Phacoemulsification

NCT04418986 | Completed Phase 4 DMC

• 1 other identifier: AR200105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in visual acuity

  After 1 month of surgery

Study Arms (2)

Control (CCI Group)

SHAM COMPARATOR

The Participants will undergo phacoemulsification with on-axis incision

Procedure: opposite clear corneal incisions (OCCI)

Study (OCCI Group)

ACTIVE COMPARATOR

The Participants will undergo phacoemulsification with opposite clear corneal incisions

Procedure: opposite clear corneal incisions (OCCI)

Interventions

opposite clear corneal incisions (OCCI) PROCEDURE

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.

Control (CCI Group); Study (OCCI Group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Rasheed University College: lead
• Baghdad Medical City: collaborator

Study Sites (1)

Ghazi al-Hariri Surgical Specialties Hospital

Baghdad, Bab-Almuadham, 12221, Iraq

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IR (1)