CataractNCT00756327
AquaLase Capsule Wash for Pediatric Eyes
An observational study of Cataract and Pediatric Cataract, run by Medical University of South Carolina at 1 site in India.
Trial summary
To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cataract, Pediatric Cataract
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2007to Jun 2009
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with bilateral cataract undergoing surgery for cataract aspiration and IOL implantation. Bilateral cataract in a child aged 6-15 years old.
Who may be able to join
- Bilateral cataract in a child aged 6-15 years old
- Informed consent from the parents/legal guardian.
Who cannot join
- traumatic cataract
- fellow eye - visually not significant cataract
- fellow eye surgery not scheduled within 3-month period after first eye surgery
- dense posterior capsule plaque
- preexisting posterior capsule defect
- subluxated cataract
Show all 9Show fewer
- high myopia (defined as axial length >24 mm)
- child with multiple disability where it may not be feasible to perform YAG laser capsulotomy in the office, if needed
- Participants with a strong likelihood of non-adherence (difficulties in adhering to follow-up schedule due to geographic distance from clinical center)
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes.
Read the detailed description
Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. Intraocular lens (IOL) implantation has been universally accepted as the standard of care for most children undergoing cataract surgery beyond infancy. Despite advances in cataract surgery in children, PCO remained a significant complication following pediatric cataract surgery. In addition to being visually disturbing, it also induces amblyopia in children and if not treated at the earliest, irreversible visual changes may occur. The younger the child, the more acute is the problem: PCO occurs faster and the effect of amblyopia is more pronounced.
To prevent opacification of the visual axis after cataract surgery, primary posterior capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. This surgical step is not routinely used in adult cataract surgery, where we prefer an intact posterior capsule. Researchers are constantly trying to find a way to avoid the need for invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. Use of AquaLase technology has shown some capability in cleaning the capsular bag during cataract surgery. Observations of this include anecdotal observation from users. AquaLase for cataract removal with the Infiniti Vision System has been used since 2003, is registered, and the FDA clearance is 510(k) number K980292. AquaLase uses pulses of warmed balanced salt solution to gently emulsify and facilitate aspiration of cataracts. The device under evaluation falls under the same FDA clearance. The unique aspect is the application tip which is intended to allow more thorough capsular bag cleaning or removal of more residual lens material than is currently being achieved. The energy source, controls, and materials are all identical to the currently marketed product. The difference is in the geometry of the distal most end of the application tip.
- Conditions
- Cataract, Pediatric Cataract
- Keywords
- pediatric eyes, bilateral cataract, IOL implantation, Aqualase capsule wash, posterior capsule opacification
- 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 posted22 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2009
- Study completionJun 2009
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.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Trivedi Rupalben, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756327
- Sponsor's protocol ID
- MRC-08-001
- Status last verified
- Aug 2009
- First submitted
- 18 Sep 2008
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AquaLase Capsule Wash for Pediatric Eyes
- ClinicalTrials.gov ID
- NCT00756327
- Acronym / sponsor ID
- MRC-08-001
- Conditions
- Cataract, Pediatric Cataract
- Keywords
- pediatric eyes, bilateral cataract, IOL implantation, Aqualase capsule wash, posterior capsule opacification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Sep 2008 (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.
To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes.
Detailed description
Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. Intraocular lens (IOL) implantation has been universally accepted as the standard of care for most children undergoing cataract surgery beyond infancy. Despite advances in cataract surgery in children, PCO remained a significant complication following pediatric cataract surgery. In addition to being visually disturbing, it also induces amblyopia in children and if not treated at the earliest, irreversible visual changes may occur. The younger the child, the more acute is the problem: PCO occurs faster and the effect of amblyopia is more pronounced.
To prevent opacification of the visual axis after cataract surgery, primary posterior capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. This surgical step is not routinely used in adult cataract surgery, where we prefer an intact posterior capsule. Researchers are constantly trying to find a way to avoid the need for invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. Use of AquaLase technology has shown some capability in cleaning the capsular bag during cataract surgery. Observations of this include anecdotal observation from users. AquaLase for cataract removal with the Infiniti Vision System has been used since 2003, is registered, and the FDA clearance is 510(k) number K980292. AquaLase uses pulses of warmed balanced salt solution to gently emulsify and facilitate aspiration of cataracts. The device under evaluation falls under the same FDA clearance. The unique aspect is the application tip which is intended to allow more thorough capsular bag cleaning or removal of more residual lens material than is currently being achieved. The energy source, controls, and materials are all identical to the currently marketed product. The difference is in the geometry of the distal most end of the application tip.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with bilateral cataract undergoing surgery for cataract aspiration and IOL implantation. Bilateral cataract in a child aged 6-15 years old.
Key inclusion criteria (2 listed)
- Bilateral cataract in a child aged 6-15 years old
- Informed consent from the parents/legal guardian.
Key exclusion criteria (9 listed)
- traumatic cataract
- fellow eye - visually not significant cataract
- fellow eye surgery not scheduled within 3-month period after first eye surgery
- dense posterior capsule plaque
- preexisting posterior capsule defect
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 17 Aug 2009.
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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.
Trivedi Rupalben, MD principal investigator
Assistant Professor
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 and Pediatric Cataract, run by Medical University of South Carolina at 1 site in India.
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 2 inclusion and 9 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 17 Aug 2009. 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 India. 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 17 Aug 2009.