Incisional Correction of Corneal Astigmatism During Phacoemulsification

NCT ID: NCT04418986

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control (CCI Group)

The Participants will undergo phacoemulsification with on-axis incision

Group Type SHAM_COMPARATOR

opposite clear corneal incisions (OCCI)

Intervention Type 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.

Study (OCCI Group)

The Participants will undergo phacoemulsification with opposite clear corneal incisions

Group Type ACTIVE_COMPARATOR

opposite clear corneal incisions (OCCI)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baghdad Medical City

OTHER

Sponsor Role collaborator

Al-Rasheed University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghazi al-Hariri Surgical Specialties Hospital

Baghdad, Bab-Almuadham, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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AR200105

Identifier Type: -

Identifier Source: org_study_id

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