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

Not Applicable

Recruiting

• Conditions: Intraocular Lens Implantation; Cataract; Humans; Ocular, Refraction
• Interventions: Device: Intraoperative aberrometer; Other: Preoperative intraocular lens calculation

• Registration Number: NCT06219252
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-11-03
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORA group	Intraoperative aberrometer	the intraocular lens calculation in this group will be optimized by the intraoperative aberrometer (ORA)
Control group	Preoperative intraocular lens calculation	Barrett universal II will be used in the control group.

Primary Outcome Measures

Name	Time	Method
spherical equivalent	90 days of the postoperative period	Spherical equivalent values at 90 days of the postoperative period

Secondary Outcome Measures

Name	Time	Method
uncorrected distance visual acuity	90 days of the postoperative period	uncorrected distance visual acuity at 90 days of the postoperative period

Trial Locations

Locations (1)

Instituto de oftalmología Fundación Conde de Valenciana; 🇲🇽 Mexico City, Cuauhtemoc, Mexico