Accuracy of IOLMASTER 700 Total Keratometry (TK)

Cataract Clinical Trial

Official title:

Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254587
• Other study ID #: AVC-005
• Status: Completed
• Start date: February 8, 2022
• Est. completion date: January 27, 2024

Study information

• Verified date: June 2024
• Source: Advanced Vision Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 27, 2024
• Est. primary completion date: January 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Hyperopia
• Myopia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Ophthalmic Partners PC	Bala-Cynwyd	Pennsylvania
United States	Solomon Eye Physicians and Surgeons	Bowie	Maryland
United States	MUSC Storm Eye Institute29425	Charleston	South Carolina
United States	Advanced Vision Care	Los Angeles	California
United States	Virginia eye consultant	Norfolk	Virginia
United States	Wolstan & Goldberg Eye Associates	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Vision Care	Clinical Research Consultants, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Keratometry Accuracy Assessment	Subjects utilizing Total Keratometry within (+/- 0.50 D, +/- 0.75 D, +/- 1.00 D) compared to the proportion of subjects utilizing traditional keratometry readings.	4 Weeks