Posterior Capsule OpacificationNCT02491918
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
A study testing cataract surgery and Intraocular lens implantation in people with Posterior Capsule Opacification and Postoperative Complications, run by Iladevi Cataract and IOL Research Center.
Trial summary
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two… Read more about this study
- Who is it for?
- Ages 15 days to 4 years
- Conditions the study is for
- Posterior Capsule Opacification, Postoperative Complications
- What is being tested?
- cataract surgery and Intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- 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 15 days to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- uncomplicated cataract,
- unilateral or bilateral cataract,
- corneal diameter >9.0mmHg
Who cannot join
- pre-existing glaucoma,
- uveitis,
- ocular comorbidity,
- microphthalmos,
- microcornea,
- parents not consenting to participate in study,
- traumatic cataract
About this study
Official title: Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.
Read the detailed description
This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :
- in the bag IOL with limbal anterior vitrectomy
- posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.
The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.
All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.
- Being tested
- cataract surgery, Intraocular lens implantation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
cataract surgery in children
Intraocular lens implantationProcedure or surgery
intraocular lens implantation in the capsular bag or optic capture
| Study group | Role | What they receive |
|---|---|---|
| In the bag IOL | Active comparator | Cataract surgery with IOL implantation in the capsular bag Receives: Procedure: cataract surgery; Procedure: Intraocular lens implantation |
| Optic Capture of IOL | Active comparator | intraocular lens implantation in the capsular bag with posterior optic capture Receives: Procedure: cataract surgery; Procedure: Intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior capsule opacification requiring surgery
opacification of visual axis
Measured: 12 months postoperatively
Secondary outcomes (3)
inflammation on slitlamp examination
cell depostis
Measured: 12 months postoperatively
inflammation on slitlamp examination
posterior synechiae
Measured: 12 months postoperatively
intraocular pressure in mmHg
glaucoma
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
- Investigators
- abhay vasavada, MS,FRCS, Study director, Iladevi Cataract & IOL Research Centre, Ahmedabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491918
- Sponsor's protocol ID
- 13-009
- Other IDs
- 2013 Research Foundation Grant
- Status last verified
- Jul 2015
- First submitted
- 29 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT02491918
- Acronym / sponsor ID
- 13-009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jul 2015 (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.
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.
Detailed description
This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :
- in the bag IOL with limbal anterior vitrectomy
- posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.
The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.
All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In the bag IOL | Active comparator | Procedure: cataract surgery, Procedure: Intraocular lens implantationCataract surgery with IOL implantation in the capsular bag |
| Optic Capture of IOL | Active comparator | Procedure: cataract surgery, Procedure: Intraocular lens implantationintraocular lens implantation in the capsular bag with posterior optic capture |
Who may qualify
- Ages
- 15 days to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- uncomplicated cataract,
- unilateral or bilateral cataract,
- corneal diameter >9.0mmHg
Key exclusion criteria (7 listed)
- pre-existing glaucoma,
- uveitis,
- ocular comorbidity,
- microphthalmos,
- microcornea,
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 |
|---|---|---|
| cataract surgerycataract surgery in children | Procedure or surgery | In the bag IOL, Optic Capture of IOL |
| Intraocular lens implantationintraocular lens implantation in the capsular bag or optic capture | Procedure or surgery | In the bag IOL, Optic Capture of IOL |
Primary outcome
Posterior capsule opacification requiring surgery
Time frame: 12 months postoperatively
opacification of visual axis
3 secondary outcomes
inflammation on slitlamp examination
Time frame: 12 months postoperatively
inflammation on slitlamp examination
Time frame: 12 months postoperatively
intraocular pressure in mmHg
Time frame: 12 months postoperatively
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 8 Jul 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.
abhay vasavada, MS,FRCS study director
Iladevi Cataract & IOL Research Centre, Ahmedabad, India
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery and Intraocular lens implantation in people with Posterior Capsule Opacification and Postoperative Complications, run by Iladevi Cataract and IOL Research Center.
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 8 Jul 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.
What does the primary outcome measure?
Posterior capsule opacification requiring surgery (time frame: 12 months 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 8 Jul 2015.