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OpenTrials
Completed

NCT Number: NCT04418986

Incisional Correction of Corneal Astigmatism During Phacoemulsification

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.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghazi al-Hariri Surgical Specialties Hospital

Baghdad, Bab-Almuadham, 12221, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opposite clear corneal incisions (OCCI)

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.

Primary outcomes

  1. Mean astigmatic correction

    Time frame: After 1 month of surgery

    Astigmatic correction change after the correction surgery

  2. Mean surgically induced astigmatism

    Time frame: After 1 month of surgery

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

Secondary outcomes

  1. Change in visual acuity

    Time frame: After 1 month of surgery

    Uncorrected visual acuity and best corrected visual acuity after the surgery

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Collaborators

  • Baghdad Medical City

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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