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RecruitingNCT06219252ORAVSCTRLUpdated May 14, 2025

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

An interventional study of Intraoperative aberrometer and Preoperative intraocular lens calculation in Intraocular Lens Implantation, Cataract and Humans, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Recruiting at 1 site in Mexico. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Intraocular Lens Implantation
  • Cataract
  • Humans
  • Ocular, Refraction

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Keywords

  • biometry
  • aberrometry
  • prospective study
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 300 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    ORA group

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

    Device: Intraoperative aberrometer

  • Active comparator
    Control group

    Barrett universal II will be used in the control group.

    Other: Preoperative intraocular lens calculation

Interventions

  • DeviceIntraoperative aberrometer

    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

  • OtherPreoperative intraocular lens calculation

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

    Also known as: Barrett Universal II

06

What researchers measure

Primary outcomes

  1. spherical equivalent

    Spherical equivalent values at 90 days of the postoperative period

    Time frame: 90 days of the postoperative period

Secondary outcomes

  1. uncorrected distance visual acuity

    uncorrected distance visual acuity at 90 days of the postoperative period

    Time frame: 90 days of the postoperative period

07

Study locations

1 of 1 sites recruiting
  • Instituto de oftalmología Fundación Conde de Valenciana
    Mexico City, Cuauhtemoc 06800, Mexico
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06219252
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
Nov 3, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 14, 2025

Study contacts

DIEGO ZAMORA - DE LA CRUZ, MD
Contact
DIEGO.ZAMORA@INSTITUTODEOFTALMOLOGIA.ORG
5554421700 ext. 3141
ANGEL NAVA - CASTAÑEDA, MD
principal investigator · INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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