Accuracy of IOLMASTER 700 Total Keratometry (TK)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-08

Study Completion Date

2024-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multicenter study to compare the accuracy of IOL calculations in post-laser vision corrected eyes that are about to undergo or have undergone cataract surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery

NCT00466908

Cataract Extraction Refractive Surgery

WITHDRAWN

Total Corneal Astigmatism Prevalence in Cataract Patients

NCT06148857

Cataract

NOT_YET_RECRUITING

IOLMASTER 700 Central Topography Workflow Study.

NCT04875247

Cataract

COMPLETED

Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

NCT03733730

Aphakia Presbyopia Astigmatism

COMPLETED NA

Refractive Outcomes Utilizing Two SS-OCT Biometers for IOL Power Calculations

NCT06801678

Cataract

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multicenter study to compare the accuracy of IOL calculations using 4 different IOL calculation methods (Haigis TK, ASCRS calculator, Barrett True K with classic K, and Barrett True K TK) performed using the preoperative biometry data from post-laser vision correct eyes that are about to undergo or have undergone cataract surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia Hyperopia Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrospective

IOLMASTER 700 TK

Intervention Type DEVICE

4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett True K Classic K, Barrett True K TK) will be performed using the preoperative biometry and post operative refraction data.

Prospective

IOLMASTER 700 TK

Intervention Type DEVICE

4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett True K Classic K, Barrett True K TK) will be performed using the preoperative biometry and post operative refraction data.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IOLMASTER 700 TK

4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett True K Classic K, Barrett True K TK) will be performed using the preoperative biometry and post operative refraction data.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults, 18 years of age or older at the time of cataract surgery.
2. Patient has had LVC and IOL cataract surgery within 3 years or is scheduled to undergo IOL cataract surgery performed for the treatment of visually significant cataracts.

Note: The only IOLs permitted for use in this study are Monofocal (ZCBOO, LI61AO, SN60WF, SA60WF, MX60E) and Toric Lenses (Tecnis 2 ZCU, ZCT, SN6ATx, SA6ATx, MX60ET).
3. Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).
4. Patients who have a manifest refraction that is myopic or hyperopic after previous LVC.
5. Patients that have biometric measurements (including Axial Length) for the IOL cataract surgery that were performed preoperatively with the IOLMaster700, including Barrett True K /TK.
6. Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only).
7. For prospective patients, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

Exclusion Criteria

1. Patients with a history of any of the following:

1. Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy
2. Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal Detachment
3. Optic neuropathy
4. Advanced glaucoma
5. Amblyopia
6. Strabismus
7. Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.
2. Patients with a previous history of small incision lenticule extraction (SMILE) surgery and/or glaucoma filtering procedure (defined as tubes or trabeculectomy) other than photorefractive keratectomy (PRK) or LASIK.
3. Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.
4. Patient has had LVC and IOL cataract surgery within 3 years or is scheduled to undergo IOL cataract surgery performed for the treatment of visually significant cataracts with the presence or intention of implanting a multifocal, extended depth of focus, accommodating and light adjustable lens (such as, but not limited to, TFAT / TFNT; DAT / DFT; ICB00/DIB/DIU/DAT; ZXT; DFW; SN6AD1; AT-50; RxSIGHT).
5. Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing).
6. Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.
7. Patient is participating in another study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No