Status:
COMPLETED
Accuracy of IOLMASTER 700 Total Keratometry (TK)
Lead Sponsor:
Advanced Vision Care
Collaborating Sponsors:
Clinical Research Consultants, Inc.
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
18+ years
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) pe...
Eligibility Criteria
Inclusion
- 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
- 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
- Amblyopia
- Strabismus
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 27 2024
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05254587
Start Date
February 8 2022
End Date
January 27 2024
Last Update
June 14 2024
Active Locations (7)
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1
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
2
Advanced Vision Care
Los Angeles, California, United States, 90067
3
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
4
Solomon Eye Physicians and Surgeons
Bowie, Maryland, United States, 20716