Congenital CataractPhase 4NCT01297153
Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
A Phase 4 study testing Intraocular Lens (Acrysof IOL) and No IOL in people with Congenital Cataract, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- Intraocular Lens (Acrysof IOL) and No IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- May 2003to May 2011
- Phase
- Phase 4
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 2 years
- Congenital cataract
- Bilateral cataracts
- IOL fixation - Bag/Ciliary fixated
Who cannot join
- Microphthalmos (Mean axial length 2 SDs less than normal for age)
- Microcornea (Horizontal corneal diameter <9.5 mm-asper that particular age)
- Iris coloboma
- PHPV
- Aniridia
- *Glaucoma - IOP more than or equal to 25 mmHg
- One eyed
- Cataract surgery already performed in fellow eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.
Read the detailed description
The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span.
Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery :
- Primary IOL implantation.
- Aphakic glasses.
- Contact lenses.
At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years.
Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.
- Conditions
- Congenital Cataract
- Being tested
- Intraocular Lens (Acrysof IOL), No IOL
- Keywords
- Congenital Cataract, Children younger than 2 years, Aphakia, Primary IOL Implantation
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Lens (Acrysof IOL)Device
Also called Hydrophobic Acrylic IOL
IOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation.
No IOLDevice
No IOL will be implanted in these eyes
| Study group | Role | What they receive |
|---|---|---|
| Aphakia | Active comparator | * The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. If it is aphakia,IOL will not be implanted.Aphakia will be corrected with aphakic glasses / contact lenses. Bilateral aphakes are given both contact lenses and glasses. So when they do not wear contact lenses they can put on aphakic glasses. Unilateral aphakes are given only contact lenses. Contact lenses should be fitted in the eye in OT immediately after the operation.
* Aphakic glasses :
Prescribed within 2 weeks of surgery for both eyes. Receives: Device: No IOL |
| Pseudophakia | Active comparator | The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. Hydrophobic Acrysof IOL is implanted.All pseudophakic children will be refracted and given the residual correction within a month of surgery. Receives: Device: Intraocular Lens (Acrysof IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual axis obscuration
Visual axis obscuration(VAO) assesed on slitlamp or under operating microscope in dilated pupil.VAO is defined as fibrous or proliferative cell growth leadind to a dull retinoscopic reflex.
Measured: 4 years
Glaucoma
Intraocular pressure (IOP) measured with Perkins handheld applanation tonometer.
Glaucoma defined as :
IOP>21 mmHg >1 occasion with any of these 3 criteria
- Optic nerve cupping asymmetry >0.2 cd ratio asymmetry , CD ratio >0.4
- Abnormal asymmetrical axial length elongation
- Corneal oedema or enlargement
Measured: 4 years
Central Corneal Thickness
Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.
Measured: 4 Years
Secondary outcomes (1)
Visual Acuity
An Objective visual assessment to be performed using Lea Grating Paddles(Grating Acuity Test developed by Lea Hyvarinen16), Cardiff Acuity Cards(Preferential Looking Test17), or ETDRS (Early Treatment of Diabetic Retinopathy Study) chart. Vision is subjectively assessed as the ability to follow or to fixate on a point source of light or on an object shown to the child.. Ocular alignment was measured using alternative cover testing. If this kind of testing was not feasible, Hirschberg testing was performed..
Measured: 4 years .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMay 2003
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Abhay R Vasavada, MS,FRCS, Principal investigator, Iladevi Cataract And IOL Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297153
- Sponsor's protocol ID
- icircAP
- Status last verified
- Jun 2011
- First submitted
- 14 Feb 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT01297153
- Acronym / sponsor ID
- icircAP
- Conditions
- Congenital Cataract
- Keywords
- Congenital Cataract, Children younger than 2 years, Aphakia, Primary IOL Implantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Feb 2011 (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.
The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.
Detailed description
The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span.
Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery :
- Primary IOL implantation.
- Aphakic glasses.
- Contact lenses.
At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years.
Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphakia | Active comparator | Device: No IOL* The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. If it is aphakia,IOL will not be implanted.Aphakia will be corrected with aphakic glasses / contact lenses. Bilateral aphakes are given both contact lenses and glasses. So when they do not wear contact lenses they can put on aphakic glasses. Unilateral aphakes are given only contact lenses. Contact lenses should be fitted in the eye in OT immediately after the operation. * Aphakic glasses : Prescribed within 2 weeks of surgery for both eyes. |
| Pseudophakia | Active comparator | Device: Intraocular Lens (Acrysof IOL)The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. Hydrophobic Acrysof IOL is implanted.All pseudophakic children will be refracted and given the residual correction within a month of surgery. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children less than 2 years
- Congenital cataract
- Bilateral cataracts
- IOL fixation - Bag/Ciliary fixated
Key exclusion criteria (8 listed)
- Microphthalmos (Mean axial length 2 SDs less than normal for age)
- Microcornea (Horizontal corneal diameter <9.5 mm-asper that particular age)
- Iris coloboma
- PHPV
- Aniridia
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 |
|---|---|---|
| Intraocular Lens (Acrysof IOL)Also: Hydrophobic Acrylic IOLIOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation. | Device | Pseudophakia |
| No IOLNo IOL will be implanted in these eyes | Device | Aphakia |
Primary outcome
Visual axis obscuration
Time frame: 4 years
Visual axis obscuration(VAO) assesed on slitlamp or under operating microscope in dilated pupil.VAO is defined as fibrous or proliferative cell growth leadind to a dull retinoscopic reflex.
Glaucoma
Time frame: 4 years
Intraocular pressure (IOP) measured with Perkins handheld applanation tonometer. Glaucoma defined as : IOP>21 mmHg >1 occasion with any of these 3 criteria 1. Optic nerve cupping asymmetry >0.2 cd ratio asymmetry , CD ratio >0.4 2. Abnormal asymmetrical axial length elongation 3. Corneal oedema or enlargement
Central Corneal Thickness
Time frame: 4 Years
Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.
1 secondary outcome
Visual Acuity
Time frame: 4 years .
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 1 Jul 2011.
Related trials for Congenital Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Not yet recruiting
Partial Range Of Field IOLs in DMEK-Enabled Procedures
Cataract, Fuchs Endothelial Corneal Dystrophy
Recruiting
Guangke Lenses in Congenital Cataract
Congenital Cataract
Not yet recruitingObservational study
Postoperative CCT in FECD vs. Non-FECD
Fuchs Endothelial Corneal Dystrophy, Cataract (Post-operative Cataract Surgery Follow-up)
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 R Vasavada, MS,FRCS principal investigator
Iladevi Cataract And IOL Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraocular Lens (Acrysof IOL) and No IOL in people with Congenital Cataract, run by Iladevi Cataract and IOL Research Center 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 4 inclusion and 8 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 1 Jul 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual axis obscuration (time frame: 4 years). The study lists 3 primary outcomes in all. 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 1 Jul 2011.