CataractPALNCT00974844
Posterior Assisted Levitation of Dropped Nucleus
An observational study of Cataract, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Dropping of nucleus is a common complication during cataract extraction by phacoemulsification. The investigators describe a new technique to retrieve the dropped nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cataract
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2009to Mar 2011
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had dropped nucleus during phacoemulsification
Who may be able to join
- Patients during cataract surgery whose nucleus will be dropped during phacoemulsification
Who cannot join
- Completely dropped nucleus touching the posterior pole
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Eye Unit III, Lyari General Hospital , Dow university of Health Sciences
Karachi, Sindh, 74200
About this study
Official title: Posterior Assisted Levitation by Pars-Plana Levitator
Dropping of nucleus is a common complication during cataract extraction by phacoemulsification. The investigators describe a new technique to retrieve the dropped nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).
Read the detailed description
Upon recognition of posterior capsular rupture and dropping of nucleus phaco prob will be withdrawn, status of the nucleus will be visualized by posterior segment non contact lens and if the nucleus found floating, pars plana levitator will be introduced through temporal pars plana, its prongs will be opened and nucleus will be grasped between prongs. Nucleus will be lifted up till the anterior chamber where phacoemulsification will be performed in a usual manner and a posterior chamber intraocular lens will be implanted if possible in the remaining bag.
- Conditions
- Cataract
- Keywords
- posterior assisted levitation, Pars Plana, Dropped nucleus, cataract, complication of, surgery
- Medical subject headings
- Cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionMar 2011
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshed Ahmed, Dow University of Health Sciences
- Investigators
- Shahid Wahab, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974844
- Sponsor's protocol ID
- DUHS-SWJA
- Acronym
- PAL
- Status last verified
- Sep 2009
- First submitted
- 24 Aug 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Assisted Levitation by Pars-Plana Levitator
- ClinicalTrials.gov ID
- NCT00974844
- Acronym / sponsor ID
- PAL / DUHS-SWJA
- Conditions
- Cataract
- Keywords
- posterior assisted levitation, Pars Plana, Dropped nucleus, cataract, complication of, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Sep 2009 (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.
Dropping of nucleus is a common complication during cataract extraction by phacoemulsification. The investigators describe a new technique to retrieve the dropped nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).
Detailed description
Upon recognition of posterior capsular rupture and dropping of nucleus phaco prob will be withdrawn, status of the nucleus will be visualized by posterior segment non contact lens and if the nucleus found floating, pars plana levitator will be introduced through temporal pars plana, its prongs will be opened and nucleus will be grasped between prongs. Nucleus will be lifted up till the anterior chamber where phacoemulsification will be performed in a usual manner and a posterior chamber intraocular lens will be implanted if possible in the remaining bag.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had dropped nucleus during phacoemulsification
Key inclusion criteria (1 listed)
- Patients during cataract surgery whose nucleus will be dropped during phacoemulsification
Key exclusion criteria (1 listed)
- Completely dropped nucleus touching the posterior pole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 24 Aug 2011.
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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.
Shahid Wahab, FCPS principal investigator
Dow University of Health Sciences
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 Dow University of Health Sciences at 1 site in Pakistan.
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 1 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 24 Aug 2011. 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 Pakistan. 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 24 Aug 2011.