Intraoperative Aberrometry vs Conventional Intraocular Lens Calculation, a Prospective Study. (ORAVSCTRL)

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Enrolling

Conditions: Cataract; Humans; Ocular, Refraction; Intraocular Lens Implantation

Treatments: Device: Intraoperative aberrometer; Other: Preoperative intraocular lens calculation

Study type: Interventional

Funder types: Other

Identifiers

NCT06219252

CI-005-2023

Details and patient eligibility

About

the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .

Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity

Full description

Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.

The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.

Enrollment: 300 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.

Exclusion criteria

• glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

ORA group

Experimental group

Description:

the intraocular lens calculation in this group will be optimized by the intraoperative aberrometer (ORA)

Treatment:

Device: Intraoperative aberrometer

Control group

Active Comparator group

Description:

Barrett universal II will be used in the control group.

Treatment:

Other: Preoperative intraocular lens calculation