Incisional Correction of Corneal Astigmatism During Phacoemulsification

Astigmatism Clinical Trial

Official title:

Incisional Correction of Corneal Astigmatism During Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418986
• Other study ID #: AR200105
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

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.

Locations

Country	Name	City	State
Iraq	Ghazi al-Hariri Surgical Specialties Hospital	Baghdad	Bab-Almuadham

Sponsors (2)

Lead Sponsor	Collaborator
Al-Rasheed University College	Baghdad Medical City

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean astigmatic correction	Astigmatic correction change after the correction surgery	After 1 month of surgery
Primary	Mean surgically induced astigmatism	Mean surgically induced astigmatism, measured by a vector-corrected method	After 1 month of surgery
Secondary	Change in visual acuity	Uncorrected visual acuity and best corrected visual acuity after the surgery	After 1 month of surgery