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Recruiting NCT06219252

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

No phase Interventional Intraocular Lens Implantation Cataract Humans Ocular, Refraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperative aberrometer, Preoperative intraocular lens calculation.
Who it may be relevant to
Registry conditions: Intraocular Lens Implantation, Cataract, Humans, Ocular, Refraction. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Intraoperative 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
  • Other Preoperative intraocular lens calculation
    the intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula

Primary outcome measures

  • spherical equivalent [Time frame: 90 days of the postoperative period]
Secondary outcome measures (1)
  • uncorrected distance visual acuity [Time frame: 90 days of the postoperative period]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Instituto de oftalmología Fundación Conde de Valenciana — Mexico City

Identifiers

NCT: NCT06219252 · CI-005-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗