Incisional Correction of Corneal Astigmatism During Phacoemulsification
Primary Purpose
Astigmatism
Status
Completed
Phase
Phase 4
Locations
Iraq
Study Type
Interventional
Intervention
opposite clear corneal incisions (OCCI)
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
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
Sites / Locations
- Ghazi al-Hariri Surgical Specialties Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control (CCI Group)
Study (OCCI Group)
Arm Description
The Participants will undergo phacoemulsification with on-axis incision
The Participants will undergo phacoemulsification with opposite clear corneal incisions
Outcomes
Primary Outcome Measures
Mean astigmatic correction
Astigmatic correction change after the correction surgery
Mean surgically induced astigmatism
Mean surgically induced astigmatism, measured by a vector-corrected method
Secondary Outcome Measures
Change in visual acuity
Uncorrected visual acuity and best corrected visual acuity after the surgery
Full Information
NCT ID
NCT04418986
First Posted
June 3, 2020
Last Updated
June 3, 2020
Sponsor
Al-Rasheed University College
Collaborators
Baghdad Medical City
1. Study Identification
Unique Protocol Identification Number
NCT04418986
Brief Title
Incisional Correction of Corneal Astigmatism During Phacoemulsification
Official Title
Incisional Correction of Corneal Astigmatism During Phacoemulsification
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Rasheed University College
Collaborators
Baghdad Medical City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (CCI Group)
Arm Type
Sham Comparator
Arm Description
The Participants will undergo phacoemulsification with on-axis incision
Arm Title
Study (OCCI Group)
Arm Type
Active Comparator
Arm Description
The Participants will undergo phacoemulsification with opposite clear corneal incisions
Intervention Type
Procedure
Intervention Name(s)
opposite clear corneal incisions (OCCI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean astigmatic correction
Description
Astigmatic correction change after the correction surgery
Time Frame
After 1 month of surgery
Title
Mean surgically induced astigmatism
Description
Mean surgically induced astigmatism, measured by a vector-corrected method
Time Frame
After 1 month of surgery
Secondary Outcome Measure Information:
Title
Change in visual acuity
Description
Uncorrected visual acuity and best corrected visual acuity after the surgery
Time Frame
After 1 month of surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ghazi al-Hariri Surgical Specialties Hospital
City
Baghdad
State/Province
Bab-Almuadham
ZIP/Postal Code
12221
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Incisional Correction of Corneal Astigmatism During Phacoemulsification
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