NCT05254587CompletedNot Applicable
Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery
Advanced Vision Care7 sites in 1 country155 target enrollmentStarted: February 8, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 155
- Locations
- 7
- Primary Endpoint
- Total Keratometry Accuracy Assessment
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults, 18 years of age or older at the time of cataract surgery.
- •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).
- •Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).
- •Patients who have a manifest refraction that is myopic or hyperopic after previous LVC.
- •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.
- •Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only).
- •For prospective patients, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
Exclusion Criteria
- •Patients with a history of any of the following:
- •Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy
- •Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal Detachment
- •Optic neuropathy
- •Advanced glaucoma
- •Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.
- •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.
- •Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.
- •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).
- •Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing).
- •Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.
- •Patient is participating in another study.
Arms & Interventions
Retrospective
Intervention: IOLMASTER 700 TK (Device)
Prospective
Intervention: IOLMASTER 700 TK (Device)
Outcomes
Primary Outcomes
Total Keratometry Accuracy Assessment
Time Frame: 4 Weeks
Subjects utilizing Total Keratometry within (+/- 0.50 D, +/- 0.75 D, +/- 1.00 D) compared to the proportion of subjects utilizing traditional keratometry readings.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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