Trials / Recruiting
RecruitingNCT06219252
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-11-03
- Primary completion
- 2026-11-30
- Completion
- 2026-12-31
- First posted
- 2024-01-23
- Last updated
- 2025-05-14
Locations
1 site across 1 country: Mexico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06219252. Inclusion in this directory is not an endorsement.