Incisional Correction of Corneal Astigmatism During Phacoemulsification

• Sponsor: Al-Rasheed University College (Other)
• Overall Status: Completed
• CT.gov ID: NCT04418986
• Collaborator: Baghdad Medical City (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Procedure: opposite clear corneal incisions (OCCI)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Incisional Correction of Corneal Astigmatism During Phacoemulsification
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mean astigmatic correction [After 1 month of surgery]

   Astigmatic correction change after the correction surgery

2. Mean surgically induced astigmatism [After 1 month of surgery]

   Mean surgically induced astigmatism, measured by a vector-corrected method

Secondary Outcome Measures

1. Change in visual acuity [After 1 month of surgery]

   Uncorrected visual acuity and best corrected visual acuity after the surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghazi al-Hariri Surgical Specialties Hospital	Baghdad	Bab-Almuadham	Iraq	12221

Sponsors and Collaborators

• Al-Rasheed University College
• Baghdad Medical City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Al-Rasheed University College
• ClinicalTrials.gov Identifier: NCT04418986
• Other Study ID Numbers: AR200105
• First Posted: Jun 5, 2020
• Last Update Posted: Jun 5, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Jun 5, 2020