Congenital Cataract SurgeryNCT01504607
Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation
An observational study of Congenital Cataract Surgery and IOL Implantation, run by Iladevi Cataract and IOL Research Center.
Trial summary
Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Congenital Cataract Surgery, IOL Implantation, Change in Corneal Endothelial Cell Morphology
- What is being tested?
- Congenital Cataract Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Oct 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Who may be able to join
- Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract \& IOL Research Center, Ahmedabad, India.
- Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Who cannot join
- Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.
About this study
Official title: Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.
The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.
- Conditions
- Congenital Cataract Surgery, IOL Implantation, Change in Corneal Endothelial Cell Morphology
- Being tested
- Congenital Cataract Surgery
- Keywords
- corneal endothelium, congenital cataract surgery, IOL implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congenital Cataract SurgeryProcedure or surgery
Congenital cataract surgery with IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| Congenital cataract surgery with IOL implantation | Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation Receives: Procedure: Congenital Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial morphology
Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively
Measured: preoperatively to 3 months postoperatively
Secondary outcomes (1)
Change in central corneal thickness
Change in central corneal thickness from preop to 3 months postop was studied
Measured: preoperatively to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Cataract SurgeryStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504607
- Sponsor's protocol ID
- ICIRC-Pedspec
- Other IDs
- 2011-13
- Status last verified
- Jan 2012
- First submitted
- 27 Dec 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vasavada AR, Praveen MR, Vasavada VA, Shah SK, Vasavada V, Trivedi RH. Corneal endothelial morphologic assessment in pediatric cataract surgery with intraocular lens implantation: a comparison of preoperative and early postoperative specular microscopy. Am J Ophthalmol. 2012 Aug;154(2):259-265.e1. doi: 10.1016/j.ajo.2012.02.018. Epub 2012 Apr 27.
PubMed 22541660
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
- ClinicalTrials.gov ID
- NCT01504607
- Acronym / sponsor ID
- ICIRC-Pedspec
- Conditions
- Congenital Cataract Surgery, IOL Implantation, Change in Corneal Endothelial Cell Morphology
- Keywords
- corneal endothelium, congenital cataract surgery, IOL implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Jan 2012 (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 surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.
The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital cataract surgery with IOL implantation | – | Procedure: Congenital Cataract SurgeryCongenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Key inclusion criteria (2 listed)
- Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract \& IOL Research Center, Ahmedabad, India.
- Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Key exclusion criteria (1 listed)
- Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.
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 |
|---|---|---|
| Congenital Cataract SurgeryCongenital cataract surgery with IOL implantation | Procedure or surgery | Congenital cataract surgery with IOL implantation |
Primary outcome
Corneal endothelial morphology
Time frame: preoperatively to 3 months postoperatively
Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively
1 secondary outcome
Change in central corneal thickness
Time frame: preoperatively to 3 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 5 Jan 2012.
- Derived from this study: PubMed 22541660Vasavada AR, Praveen MR, Vasavada VA, Shah SK, Vasavada V, Trivedi RH. Corneal endothelial morphologic assessment in pediatric cataract surgery with intraocular lens implantation: a comparison of preoperative and early postoperative specular microscopy. Am J Ophthalmol. 2012 Aug;154(2):259-265.e1. doi: 10.1016/j.ajo.2012.02.018. Epub 2012 Apr 27.
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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 Congenital Cataract Surgery and IOL Implantation, 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 2 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 5 Jan 2012. 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?
Corneal endothelial morphology (time frame: preoperatively to 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504607, which also lists 1 linked publication.
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 5 Jan 2012.