Incisional Correction of Corneal Astigmatism During Phacoemulsification

Al-Rasheed University College

Status and phase: Completed; Phase 4

Conditions: Astigmatism

Treatments: Procedure: opposite clear corneal incisions (OCCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04418986

AR200105

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control (CCI Group)

Sham Comparator group

Description:

The Participants will undergo phacoemulsification with on-axis incision

Treatment:

Procedure: opposite clear corneal incisions (OCCI)

Study (OCCI Group)

Active Comparator group

Description:

The Participants will undergo phacoemulsification with opposite clear corneal incisions

Treatment:

Procedure: opposite clear corneal incisions (OCCI)