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Incisional Correction of Corneal Astigmatism During Phacoemulsification

Incisional Correction of Corneal Astigmatism During Phacoemulsification

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04418986
Enrollment
40
Registered
2020-06-05
Start date
2019-07-01
Completion date
2019-09-30
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

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.

Interventions

PROCEDUREopposite 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.

Sponsors

Baghdad Medical City
CollaboratorOTHER
Al-Rasheed University College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean astigmatic correctionAfter 1 month of surgeryAstigmatic correction change after the correction surgery
Mean surgically induced astigmatismAfter 1 month of surgeryMean surgically induced astigmatism, measured by a vector-corrected method

Secondary

MeasureTime frameDescription
Change in visual acuityAfter 1 month of surgeryUncorrected visual acuity and best corrected visual acuity after the surgery

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026