CataractNCT02058394
Retained Lens Fragments After Phacoemulsification
An observational study of Cataract, run by Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
Who may be able to join
- Routine cataract surgery with phacoemulsification
Who cannot join
- Pre-existing macular edema
- Active uveitis
- Intraocular exclusion surgeries
- Significant ocular trauma
- Evidence of phacodonesis or zonular weakness .
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
New York, New York, 10003
About this study
Official title: Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Phacoemulsification
- Keywords
- Retained nuclear lens fragments, Phacoemulsification, Cataract Surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
| Study group | Role | What they receive |
|---|---|---|
| Cataract Phacoemulsification | Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification. Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular edema
Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively
Measured: 1 month postoperatively
Secondary outcomes (7)
Intraocular inflammation
Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively
Measured: 1 month postoperativley
Elevated intraocular pressure
Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively
Measured: 1 month postoperatively
Macular Edema
Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively
Measured: 1 week postoperatively
Intraocular Inflammation
Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively
Measured: 1 week postoperatively
Elevated Intraocular Pressure
Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively
Measured: 1 week postoperatively
Macular Edema
Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively
Measured: 3 months postoperatively
Intraocular Inflammation
Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ritterband, Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
- Investigators
- David Ritterband, MD, Principal investigator, Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058394
- Sponsor's protocol ID
- 12.08
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
- ClinicalTrials.gov ID
- NCT02058394
- Acronym / sponsor ID
- 12.08
- Conditions
- Cataract
- Keywords
- Retained nuclear lens fragments, Phacoemulsification, Cataract Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PCUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 10 Feb 2014 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Phacoemulsification | – | Procedure: PhacoemulsificationSubjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
Key inclusion criteria (1 listed)
- Routine cataract surgery with phacoemulsification
Key exclusion criteria (5 listed)
- Pre-existing macular edema
- Active uveitis
- Intraocular exclusion surgeries
- Significant ocular trauma
- Evidence of phacodonesis or zonular weakness .
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 |
|---|---|---|
| PhacoemulsificationSubjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification. | Procedure or surgery | Cataract Phacoemulsification |
Primary outcome
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
7 secondary outcomes
Intraocular inflammation
Time frame: 1 month postoperativley
Elevated intraocular pressure
Time frame: 1 month postoperatively
Macular Edema
Time frame: 1 week postoperatively
Intraocular Inflammation
Time frame: 1 week postoperatively
Elevated Intraocular Pressure
Time frame: 1 week postoperatively
Macular Edema
Time frame: 3 months postoperatively
Intraocular Inflammation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
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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.
David Ritterband, MD principal investigator
Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Feb 2014. 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 United States. 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?
Results are not available in the source record.
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?
Macular edema (time frame: 1 month postoperatively). 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 10 Feb 2014.