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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219252
Acronym
ORAVSCTRL
Enrollment
300
Registered
2024-01-23
Start date
2023-11-03
Completion date
2026-12-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Humans, Intraocular Lens Implantation, Ocular, Refraction

Keywords

biometry, aberrometry, prospective study

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.

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

OTHERPreoperative intraocular lens calculation

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

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

None of the patients will be informed in what group they are assigned

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
spherical equivalent90 days of the postoperative periodSpherical equivalent values at 90 days of the postoperative period

Secondary

MeasureTime frameDescription
uncorrected distance visual acuity90 days of the postoperative perioduncorrected distance visual acuity at 90 days of the postoperative period

Countries

Mexico

Contacts

Primary ContactDIEGO ZAMORA - DE LA CRUZ, MD
DIEGO.ZAMORA@INSTITUTODEOFTALMOLOGIA.ORG5554421700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026