BlindnessCapsulotomyNCT00964613
Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification
An observational study of Blindness, run by Dow University of Health Sciences.
Trial summary
Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the people become blind due to posterior capsular opacification. The only solution for this problem is LASER capsulotomy. Laser machine is not available in remote areas especially in underdeveloped countries. Read more about this study
- Who is it for?
- Ages 1 year to 95 years
- Conditions the study is for
- Blindness
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 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 1 year to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients having posterior capsular opacification
Who may be able to join
- Patients with Posterior capsular opacification
- Both Sexes
- All ages
Who cannot join
- Retinal disease
- Uncontrolled Glaucoma
- Corneal opacity
About this study
Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the people become blind due to posterior capsular opacification. The only solution for this problem is LASER capsulotomy. Laser machine is not available in remote areas especially in underdeveloped countries. The solution of this problem is surgical capsulotomy which can be performed any where.
Read the detailed description
posterior capsular opacification is treated by YAG laser capsulotomy. this require sophisticated technology ans specific environment which is not possible in underdeveloped countries. we describe a method in which posterior capsular opacification could be managed by using only a 27 Gauge needle through pars plana. opacified posterior capsule is under tension that is why a small puncture results in a large central opening
- Conditions
- Blindness
- Keywords
- Pars Plana, Surgical Capsulotomy, Posterior capsule opacification, visual outcome, Complications
- Medical subject headings
- Blindness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Ministry of Health
- Responsible party
- Principal investigator, Jamshed Ahmed, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964613
- Sponsor's protocol ID
- Surgical Capsulotomy
- Acronym
- Capsulotomy
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2009
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification
- ClinicalTrials.gov ID
- NCT00964613
- Acronym / sponsor ID
- Capsulotomy / Surgical Capsulotomy
- Conditions
- Blindness
- Keywords
- Pars Plana, Surgical Capsulotomy, Posterior capsule opacification, visual outcome, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Collaborators
- Pakistan Ministry of Health
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Aug 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.
Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the people become blind due to posterior capsular opacification. The only solution for this problem is LASER capsulotomy. Laser machine is not available in remote areas especially in underdeveloped countries. The solution of this problem is surgical capsulotomy which can be performed any where.
Detailed description
posterior capsular opacification is treated by YAG laser capsulotomy. this require sophisticated technology ans specific environment which is not possible in underdeveloped countries. we describe a method in which posterior capsular opacification could be managed by using only a 27 Gauge needle through pars plana. opacified posterior capsule is under tension that is why a small puncture results in a large central opening
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having posterior capsular opacification
Key inclusion criteria (3 listed)
- Patients with Posterior capsular opacification
- Both Sexes
- All ages
Key exclusion criteria (3 listed)
- Retinal disease
- Uncontrolled Glaucoma
- Corneal opacity
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 7 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness, run by Dow University of Health Sciences.
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 3 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 7 Aug 2015.