ClinicalTrials.gg
Sign In
CompletedNCT01615861Updated Nov 14, 2019

Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

An interventional study of IOL implantation and IOL Implantation in Cataract, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-11-14.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Cataract

Browse trials for

03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 103 is above the median of 80 across 1,171 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

Browse Bausch & Lomb Incorporated studies →All Bausch Health Companies Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    IOL implantation

    Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)

    Procedure: IOL implantation · Device: IOL Implantation

Interventions

  • ProcedureIOL implantation

    Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.

  • DeviceIOL Implantation

    Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Corrected distance visual acuity (CDVA)

    Time frame: 6 months

Secondary outcomes

  1. Incision size

    Incision size before and after implantation

    Time frame: 6 Months

  2. Refraction

    Manifest refraction spherical equivalent. Accuracy to target refraction

    Time frame: 6 Months

  3. Visual Acuity

    Uncorrected distance visual acuity (UDVA)

    Time frame: 6 Months

  4. EPCO

    3 mm evaluation of posterior capsule opacification (EPCO) score

    Time frame: 24 Months

  5. Lens decentration

    Time frame: 6 Months

  6. Laser capsulotomy

    Removal of post-surgical, posterior capsular opacification (PCO)

    Time frame: 24 Months

07

Study locations

1 site
  • Bausch & Lomb
    Labège, 31670, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2012 to primary completion in Jun 2015, 31 months.

Of 185 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 31 months is above that.

Counting every sponsor, half of 501 studies reached it within 17 months; a quarter within 9 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2012
First posted
Jun 11, 2012
StartActual
Nov 8, 2012
Primary completionActual
Jun 16, 2015
CompletionActual
Jun 16, 2015
Last update
Nov 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01615861
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Jun 11, 2012
Start date
Nov 8, 2012
Primary completion
Jun 16, 2015
Completion
Jun 16, 2015
Last update
Nov 14, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract →

Other studies from this sponsor

Bausch & Lomb Incorporated →

Start the discussion