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Retained Lens Fragments After Phacoemulsification

Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02058394
Enrollment
500
Registered
2014-02-10
Start date
2012-03-31
Completion date
2015-03-31
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Retained nuclear lens fragments, Phacoemulsification, Cataract Surgery

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.

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.

Interventions

PROCEDUREPhacoemulsification

Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Sponsors

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Macular edema1 month postoperativelyProportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively

Secondary

MeasureTime frameDescription
Intraocular inflammation1 month postoperativleyProportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively
Elevated intraocular pressure1 month postoperativelyProportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively
Intraocular Inflammation1 week postoperativelyProportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively
Elevated Intraocular Pressure1 week postoperativelyProportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively
Macular Edema1 week postoperativelyProportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively

Other

MeasureTime frameDescription
Surgical ComplicationsIntraoperativelyProportion of eyes with surgical adverse events.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026