Clinical trial NCT05254587: Accuracy of IOLMASTER 700 Total Keratometry (TK)
Official title: Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Hyperopia
Cataract
Keywords: Laser Vision Correction
Cataract Surgery
Lead sponsor: Advanced Vision Care
Sponsor class: OTHER
Collaborators: name: Clinical Research Consultants, Inc.
First posted: 2022-02-24
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have had laser vision correction and cataract surgery (retrospective cohort) or have had laser vision correction surgery and are scheduled for cataract surgery (prospective cohort).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Keratometry Accuracy Assessment
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Bowie
country: United States
facility: Solomon Eye Physicians and Surgeons
state: Maryland
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners PC
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Storm Eye Institute29425
state: South Carolina
city: Norfolk
country: United States
facility: Virginia eye consultant
state: Virginia
Study officials:
affiliation: Advanced Vision Care
name: Nicole Fram, MD
role: PRINCIPAL_INVESTIGATOR
References: