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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
Al-Rasheed University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 3, 2020
Last Updated
June 3, 2020
Sponsor
Al-Rasheed University College
Collaborators
Baghdad Medical City
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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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