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Retained Lens Fragments After Phacoemulsification

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ClinicalTrials.gov Identifier: NCT02058394
Recruitment Status : Unknown
Verified February 2014 by David Ritterband, Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
David Ritterband, Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC

Brief Summary:
The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.

Condition or disease Intervention/treatment
Cataract Procedure: Phacoemulsification

Detailed Description:
In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
Study Start Date : March 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Cataract Phacoemulsification
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
Procedure: Phacoemulsification
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.




Primary Outcome Measures :
  1. Macular edema [ Time Frame: 1 month postoperatively ]
    Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively


Secondary Outcome Measures :
  1. Intraocular inflammation [ Time Frame: 1 month postoperativley ]
    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively

  2. Elevated intraocular pressure [ Time Frame: 1 month postoperatively ]
    Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively

  3. Macular Edema [ Time Frame: 1 week postoperatively ]
    Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively

  4. Intraocular Inflammation [ Time Frame: 1 week postoperatively ]
    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively

  5. Elevated Intraocular Pressure [ Time Frame: 1 week postoperatively ]
    Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively

  6. Macular Edema [ Time Frame: 3 months postoperatively ]
    Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively

  7. Intraocular Inflammation [ Time Frame: 3 months ]
    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively


Other Outcome Measures:
  1. Surgical Complications [ Time Frame: Intraoperatively ]
    Proportion of eyes with surgical adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
Criteria

Inclusion Criteria:

  • Routine cataract surgery with phacoemulsification

Exclusion Criteria:

  • Pre-existing macular edema
  • Active uveitis
  • Intraocular exclusion surgeries
  • Significant ocular trauma
  • Evidence of phacodonesis or zonular weakness .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058394


Locations
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United States, New York
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
New York, New York, United States, 10003
Sponsors and Collaborators
Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC
Investigators
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Principal Investigator: David Ritterband, MD Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC
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Responsible Party: David Ritterband, MD, Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC
ClinicalTrials.gov Identifier: NCT02058394    
Other Study ID Numbers: 12.08
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014
Keywords provided by David Ritterband, Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC:
Retained nuclear lens fragments
Phacoemulsification
Cataract Surgery
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases