N/A N=100 Treatment

Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT04747834 ↗

Enrolled (actual)

100

Serious AEs

1.0%

Results posted

Jun 2024

Primary outcome: Primary: Total Lens Removal Time — 76.0; 80.1 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MICOR-304 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Carl Zeiss Meditec, Inc.
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Lens Removal Time	76.0; 80.1	—
PRIMARY Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure	40.7; 35.3	—
SECONDARY Total Surgical Procedure Time	486.3; 440.0	—
SECONDARY UCVA at 1-Day	14; 15; 13; 10; 7; 8	—
SECONDARY BCDVA at 1 Week	1; 0; 30; 36; 10; 11	—
SECONDARY BCDVA at 1 Month	2; 3; 31; 35; 8; 10	—
SECONDARY Change in Corneal Thickness	542.9; 540.2; 620.5; 641.1; 559.4; 563.0	—
SECONDARY Corneal Edema	44; 56; 0; 0	—
SECONDARY Corneal Edema 1 Day Postoperative	27; 18; 8; 19; 8; 16	—
SECONDARY Corneal Edema 1-Week Postoperative	43; 53; 1; 2; 0; 1	—
SECONDARY Corneal Edema 1 Month Postoperative	43; 55; 0; 0	—
SECONDARY Corneal Cells	43; 55; 0; 0	—
SECONDARY Corneal Cells	43; 55; 0; 0	—
SECONDARY Corneal Cells	43; 55; 0; 0	—
SECONDARY Corneal Cells	43; 55; 0; 0	—
SECONDARY Anterior Chamber Flare	43; 55; 0; 0	—
SECONDARY Anterior Chamber Flare	43; 55; 0; 0	—
SECONDARY Anterior Chamber Flare	43; 55; 0; 0	—
SECONDARY Anterior Chamber Flare	43; 55; 0; 0	—
SECONDARY Posterior Capsule Opacification	39; 47; 3; 6; 1; 1	—
SECONDARY Posterior Capsule Opacification	39; 47; 3; 6; 1; 1	—
SECONDARY Posterior Capsule Opacificaiton	43; 56; 1; 0	—
SECONDARY Posterior Capsule Opacification	39; 47; 3; 6; 1; 1	—
SECONDARY Corneal Staining Erosion	43; 55; 0; 0	—
SECONDARY Corneal Staining Erosion	43; 55; 0; 0	—
SECONDARY Corneal Staining Erosion	43; 55; 0; 0	—
SECONDARY Corneal Staining Erosion	43; 55; 0; 0	—
SECONDARY Other Slit-Lamp Findings	6; 5; 37; 50	—
SECONDARY Other Slit-Lamp Findings	6; 5; 37; 50	—
SECONDARY Other Slit-Lamp Findings	6; 5; 37; 50	—
SECONDARY Other Slit-Lamp Findings	6; 5; 37; 50	—
SECONDARY Macula	36; 51; 7; 4	—
SECONDARY Macula	36; 51; 7; 4	—
SECONDARY Disc Appearance	33; 53; 10; 2	—
SECONDARY Disc Appearance	33; 53; 10; 2	—
SECONDARY Vessels	43; 54; 0; 1	—
SECONDARY Vessels	43; 54; 0; 1	—
SECONDARY Periphery	42; 48; 1; 7	—
SECONDARY Periphery	42; 48; 1; 7	—

Summary

The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.

Eligibility Criteria

Inclusion Criteria

Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits
Willing and able to understand and complete the informed consent document
Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
Subjects ≥ 18 years of age
Clear intraocular media, other than cataract

Exclusion Criteria

Polar cataracts
Zonular instability
History of dry eye treatments/devices and or dry eye medications other than artificial tears.
Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit
Subjects that are pregnant, lactating or planning to become pregnant during the course of the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04747834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.