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NCT Number: NCT06219252

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

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

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Key information

Conditions

Intraocular Lens Implantation Cataract Eye Diseases Humans Lens Diseases Ocular, Refraction

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de oftalmología Fundación Conde de Valenciana

Mexico City, Cuauhtemoc, 06800, Mexico

Location status: Recruiting

Location contact

Diego Zamora- de la Cruz, MD

CONTACT

[email protected]

5554421700 ext. 3714

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Intraoperative aberrometer

Device

the patient intraocular lens will be optimized during the aphakic period after cataract extraction and before intraocular lens implantation, this will produce a possible change in the dioptric power of the intraocular lens

Other names: ORA

Preoperative intraocular lens calculation

Other

the intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula

Other names: Barrett Universal II

Primary outcomes

  1. spherical equivalent

    Time frame: 90 days of the postoperative period

    Spherical equivalent values at 90 days of the postoperative period

Secondary outcomes

  1. uncorrected distance visual acuity

    Time frame: 90 days of the postoperative period

    uncorrected distance visual acuity at 90 days of the postoperative period

Study contacts

Contact information is provided by the study sponsor or research team.

DIEGO ZAMORA - DE LA CRUZ, MD

CONTACT

[email protected]

5554421700 ext. 3141

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Intraoperative Aberrometry vs Conventional Introcular Lens Calculation ( Barrett Universal II / Barrett True K ), Refractive and Visual Outcomes, a Prospective Study.

Acronym: ORAVSCTRL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2024
Registry last updated
May 14, 2025

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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