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

Cataract Clinical Trial

— ORAVSCTRL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219252
• Other study ID #: CI-005-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: DIEGO ZAMORA - DE LA CRUZ, MD
• Phone: 5554421700
• Email: DIEGO.ZAMORA[@]INSTITUTODEOFTALMOLOGIA.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Humans
• Intraocular Lens Implantation

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto de oftalmología Fundación Conde de Valenciana	Mexico City	Cuauhtemoc

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spherical equivalent	Spherical equivalent values at 90 days of the postoperative period	90 days of the postoperative period
Secondary	uncorrected distance visual acuity	uncorrected distance visual acuity at 90 days of the postoperative period	90 days of the postoperative period