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

NCT06219252 | Recruiting FDA Device

• 1 other identifier: CI-005-2023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Intraocular Lens Implantation; Cataract; Humans; Ocular, Refraction

Keywords

biometry; aberrometry; prospective study

Outcome Measures

Primary Outcomes (1)

• spherical equivalent

  Spherical equivalent values at 90 days of the postoperative period

  90 days of the postoperative period

Secondary Outcomes (1)

• uncorrected distance visual acuity

  90 days of the postoperative period

Study Arms (2)

ORA group

EXPERIMENTAL

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

Device: Intraoperative aberrometer

Control group

ACTIVE COMPARATOR

Barrett universal II will be used in the control group.

Other: Preoperative intraocular lens calculation

Interventions

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

Also known as: ORA

ORA group

Preoperative intraocular lens calculation OTHER

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

Also known as: Barrett Universal II

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de oftalmología Fundación Conde de Valenciana

Mexico City, Cuauhtemoc, 06800, Mexico

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• ANGEL NAVA - CASTAÑEDA, MD

  INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DIEGO ZAMORA - DE LA CRUZ, MD

CONTACT

5554421700; DIEGO.ZAMORA@INSTITUTODEOFTALMOLOGIA.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: None of the patients will be informed in what group they are assigned
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: November 3, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

ME (1)