CataractNCT01615861
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
A study testing IOL implantation in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in France.
Trial summary
The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases V4 (6M) endpoint: primary analysis V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- IOL implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2012to 16 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have clear intraocular media other than cataract in the study eye.
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.
Who cannot join
- Subjects with ocular malformation in the study eye.
- Subjects who have had previous surgery in the study eye.
- Subjects with uncontrolled glaucoma in either eye.
- Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
- Subjects using medications known to potentially complicate cataract surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases
- V4 (6M) endpoint: primary analysis
- V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
- Conditions
- Cataract
- Being tested
- IOL implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantationProcedure or surgery
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
IOL ImplantationDevice
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation | Experimental | Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS) Receives: Procedure: IOL implantation; Device: IOL Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Corrected distance visual acuity (CDVA)
Measured: 6 months
Secondary outcomes (6)
Incision size
Incision size before and after implantation
Measured: 6 Months
Refraction
Manifest refraction spherical equivalent. Accuracy to target refraction
Measured: 6 Months
Visual Acuity
Uncorrected distance visual acuity (UDVA)
Measured: 6 Months
EPCO
3 mm evaluation of posterior capsule opacification (EPCO) score
Measured: 24 Months
Lens decentration
Measured: 6 Months
Laser capsulotomy
Removal of post-surgical, posterior capsular opacification (PCO)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study start8 Nov 2012
- Primary completion16 Jun 2015
- Study completion16 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615861
- Sponsor's protocol ID
- 714
- Status last verified
- Nov 2019
- First submitted
- 29 May 2012
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
- ClinicalTrials.gov ID
- NCT01615861
- Acronym / sponsor ID
- 714
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2012 (actual)
- Primary completion
- 16 Jun 2015 (actual)
- Study completion
- 16 Jun 2015 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases
- V4 (6M) endpoint: primary analysis
- V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL implantation | Experimental | Procedure: IOL implantation, Device: IOL ImplantationHydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have clear intraocular media other than cataract in the study eye.
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.
Key exclusion criteria (5 listed)
- Subjects with ocular malformation in the study eye.
- Subjects who have had previous surgery in the study eye.
- Subjects with uncontrolled glaucoma in either eye.
- Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
- Subjects using medications known to potentially complicate cataract surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL implantationMicro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique. | Procedure or surgery | IOL implantation |
| IOL ImplantationMicro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique. | Device | IOL implantation |
Primary outcome
Visual Acuity
Time frame: 6 months
Corrected distance visual acuity (CDVA)
6 secondary outcomes
Incision size
Time frame: 6 Months
Refraction
Time frame: 6 Months
Visual Acuity
Time frame: 6 Months
EPCO
Time frame: 24 Months
Lens decentration
Time frame: 6 Months
Laser capsulotomy
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.