Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03733730
Other study ID # ILR431b-P001
Secondary ID P040020
Status Completed
Phase N/A
First received
Last updated
Start date November 27, 2018
Est. completion date October 14, 2022

Study information

Verified date October 2023
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.


Description:

If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.


Recruitment information / eligibility

Status Completed
Enrollment 2449
Est. completion date October 14, 2022
Est. primary completion date October 14, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Preoperative cataract in the study eye(s) - Planned implantation in at least one eye with: - Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020 - Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020. - Able to comprehend and sign a statement of informed consent - Willing and able to complete all required postoperative visits - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery) - History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis) - Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent) - Other protocol-specified exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
Procedure:
Cataract Surgery
Routine small incision cataract surgery with IOL implantation

Locations

Country Name City State
Puerto Rico Centro Oftalmologico Metropolitano San Juan
United States Kleinman Evangelista Eye Center of Texas Arlington Texas
United States Keystone Research Austin Texas
United States Chu Vision Institute Bloomington Minnesota
United States Cincinnati Eye Institute Cincinnati Ohio
United States Rand Eye Institute Deerfield Beach Florida
United States Central Florida Eye Specialists DeLand Florida
United States Trinity Research Group Dothan Alabama
United States El Paso Eye Surgeons El Paso Texas
United States Bergstrom Eye Research Fargo North Dakota
United States Eye Center of Northern Colorado, PC Fort Collins Colorado
United States Chu Eye Institute Fort Worth Texas
United States InSight Vision Center Fresno California
United States Gainesville Eye Associates Gainesville Georgia
United States Baylor College of Medicine Alkek Eye Center Houston Texas
United States Berkeley Eye Center Houston Texas
United States Houston Eye Associates Houston Texas
United States Moyes Eye Center Kansas City Missouri
United States Harvard Eye Associates Laguna Hills California
United States Sabates Eye Center Leawood Kansas
United States Senior Health Services Louisville Kentucky
United States Piedmont Eye Center Lynchburg Virginia
United States Mid Florida Eye Center Mount Dora Florida
United States Vision for Life Nashville Tennessee
United States Raymond Fong Eye Care New York New York
United States Durrie Vision Overland Park Kansas
United States Eye Doctors of Arizona Phoenix Arizona
United States Seeta Eye Center Poughkeepsie New York
United States Vistar Eye Center Roanoke Virginia
United States The Eye Institute of Utah Salt Lake City Utah
United States Northwest Eye Surgeons Seattle Washington
United States Newsom Eye and Laser Center Sebring Florida
United States Willis-Knighton Eye Institute South Shreveport Louisiana
United States Carolina Eye Associates Southern Pines North Carolina
United States Associated Eye Care Stillwater Minnesota
United States SightTrust Eye Institute Sunrise Florida
United States Wolstan Goldberg Eye Associates Torrance California
United States St. Louis Eye Institute Town And Country Missouri

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Primary Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Secondary Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Secondary Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Secondary Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
See also
  Status Clinical Trial Phase
Completed NCT05326607 - Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia N/A
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Completed NCT05495971 - Extended Depth of Focus Contact Lenses for Presbyopia N/A
Completed NCT05464732 - Vivity IOL: Emmetropia Compared to Monovision. N/A
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Active, not recruiting NCT04151550 - Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines) N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Completed NCT02554396 - Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia Phase 2
Completed NCT02235831 - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance N/A
Completed NCT02214797 - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses N/A
Enrolling by invitation NCT01443585 - Clinical Evaluation of a Progressive Addition Lens (PAL) N/A
Completed NCT01591499 - Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal N/A
Completed NCT04983589 - A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily Phase 3
Completed NCT02740010 - The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Recruiting NCT05796453 - Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix N/A
Completed NCT02516306 - A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia Phase 1/Phase 2
Completed NCT05359380 - The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
Not yet recruiting NCT04522427 - Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery N/A
Completed NCT03688425 - Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes N/A
Recruiting NCT06053463 - Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers N/A