Nuclear Sclerotic CataractNCT00406263
Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectomy Surgery and Controls
An observational study of Nuclear Sclerotic Cataract, run by Barnes Retina Institute at 1 site in United States.
Trial summary
Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nuclear Sclerotic Cataract
- What is being tested?
- Scheimpflug crystalline lens photographs
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Oct 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing vitrectony surgery and controls
Who may be able to join
- phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
- controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
- age 18 and older
Who cannot join
- any eye that is pseudophakic,
- has had previous vitreoretinal surgery,
- has had previous intravitreal injection,
- previous intraocular inflammatory condition such as uveitis,
- previous irradiation,
- any patient with a history of ocular malignancy,
- history of infectious intraocular condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectony Surgery and Controls
Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.
Read the detailed description
Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.
- Conditions
- Nuclear Sclerotic Cataract
- Being tested
- Scheimpflug crystalline lens photographs
- Keywords
- nuclear sclerotic cataract, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheimpflug crystalline lens photographsProcedure or surgery
scheimpflug photographs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nuclear Sclerotic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhonda Weeks, Barnes Retina Institute
- Investigators
- Nancy M Holekamp, MD, Principal investigator, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406263
- Sponsor's protocol ID
- 06-1016
- Status last verified
- Jul 2016
- First submitted
- 30 Nov 2006
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectony Surgery and Controls
- ClinicalTrials.gov ID
- NCT00406263
- Acronym / sponsor ID
- 06-1016
- Conditions
- Nuclear Sclerotic Cataract
- Keywords
- nuclear sclerotic cataract, cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Dec 2006 (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.
Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.
Detailed description
Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing vitrectony surgery and controls
Key inclusion criteria (3 listed)
- phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
- controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
- age 18 and older
Key exclusion criteria (7 listed)
- any eye that is pseudophakic,
- has had previous vitreoretinal surgery,
- has had previous intravitreal injection,
- previous intraocular inflammatory condition such as uveitis,
- previous irradiation,
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 |
|---|---|---|
| Scheimpflug crystalline lens photographsscheimpflug photographs | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 27 Jul 2016.
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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.
Nancy M Holekamp, MD principal investigator
Barnes Retina Institute
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 Nuclear Sclerotic Cataract, run by Barnes Retina Institute 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 3 inclusion and 7 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 27 Jul 2016. 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?
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.
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 27 Jul 2016.