Accuracy of IOLMASTER 700 Total Keratometry (TK)

• Sponsor: Advanced Vision Care (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05254587
• Collaborator: Clinical Research Consultants, Inc. (Industry)
• Enrollment: 200
• Locations: 5
• Anticipated Duration (Months): 22.7
• Patients Per Site: 40
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Cataract	Device: IOLMASTER 700 TK

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery
• Actual Study Start Date: Feb 8, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Retrospective	Device: IOLMASTER 700 TK; 4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett Ture K Classic K, Barrett True K TK) will be performed using the preoperative biometry data.
Prospective	Device: IOLMASTER 700 TK; 4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett Ture K Classic K, Barrett True K TK) will be performed using the preoperative biometry data.

Outcome Measures

Primary Outcome Measures

1. Total Keratometry Accuracy Assessment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).

2. Patients who have a manifest refraction that is myopic or hyperopic after previous LVC.

3. 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.

4. Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only).

5. 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:

2. Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy

3. Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal Detachment

4. Optic neuropathy

5. Advanced glaucoma

6. Amblyopia

7. Strabismus

8. Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.

9. 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.

10. Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.

11. 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).

12. Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing).

13. Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.

14. Patient is participating in another study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Vision Care	Los Angeles	California	United States	90067
2	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
3	Solomon Eye Physicians and Surgeons	Bowie	Maryland	United States	20716
4	Ophthalmic Partners PC	Bala-Cynwyd	Pennsylvania	United States	19004
5	MUSC Storm Eye Institute29425	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Advanced Vision Care
• Clinical Research Consultants, Inc.

Investigators

• Principal Investigator: Nicole Fram, MD, Advanced Vision Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Advanced Vision Care
• ClinicalTrials.gov Identifier: NCT05254587
• Other Study ID Numbers: AVC-005
• First Posted: Feb 24, 2022
• Last Update Posted: Feb 24, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Advanced Vision Care: Laser Vision Correction; Cataract Surgery
• Additional relevant MeSH terms: Cataract; Hyperopia

Study Results

No Results Posted as of Feb 24, 2022