InflammationPhase 4NCT00986076
Clinical Trial on Anti-inflammatory Effect of Low-Molecular Weight Heparin in Pediatric Cataract Surgery
A Phase 4 study testing Enoxaparin and Balanced Salt Solution in people with Inflammation, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
The purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Inflammation
- What is being tested?
- Enoxaparin and Balanced Salt Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2008to Sep 2009
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (0-15 years) with congenital cataract scheduled for surgery with IOL implantation and informed consent from the parents/legal guardian
Who cannot join
- Preoperative: Associated ocular anomalies (uveitis, microphthalmos, persistent fetal vasculature, aniridia, glaucoma, iris coloboma), traumatic cataract
- Intraoperative: Inability to implant IOL in the capsular bag, intraoperative complications- iris trauma, vitreous disturbance, descemet's detachment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery
The purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (IOL) implantation.
Read the detailed description
Despite advances in cataract surgery in children, postoperative inflammation is a significant complication following pediatric cataract surgery. Any drug that prevents or decreases this inflammation would be beneficial.
Heparin has anti-inflammatory and antiproliferative effects as well as anticoagulant properties. Several studies on animal and adult human eyes show that adding heparin to the irrigating solution during cataract surgery results in less disturbance of the blood-aqueous barrier and helps prevent posterior capsule opacification (PCO).
A prospective, randomized, controlled and masked study is mandatory to evaluate the anti-inflammatory effect of Low-molecular weight Heparin for pediatric cataract surgery
- Conditions
- Inflammation
- Being tested
- Enoxaparin, Balanced Salt Solution
- Keywords
- Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Clexane(Aventis)
Enoxaparin 40 mg / 500 ml in Balanced Salt Solution
Balanced Salt SolutionDrug
Also called BSS
Intraocular infusion of Balanced Salt solution
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin infusion | Experimental | Congenital Cataract Surgery with IOL implantation
Intraocular infusion of Enoxaparin Receives: Drug: Enoxaparin |
| Balanced Salt Solution Infusion | Placebo comparator | Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution Receives: Drug: Balanced Salt Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Segment Inflammation
Measured: 1 week
Secondary outcomes (1)
Anterior Segment inflammation
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Viraj A Vasavada, MS, Principal investigator, Iladevi Cataract & IOL Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986076
- Sponsor's protocol ID
- 08-010
- Status last verified
- Sep 2009
- First submitted
- 26 Sep 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kruger A, Amon M, Abela-Formanek C, Schild G, Kolodjaschna J, Schauersberger J. Effect of heparin in the irrigation solution on postoperative inflammation and cellular reaction on the intraocular lens surface. J Cataract Refract Surg. 2002 Jan;28(1):87-92. doi: 10.1016/s0886-3350(01)00861-6.
PubMed 11777715Rumelt S, Stolovich C, Segal ZI, Rehany U. Intraoperative enoxaparin minimizes inflammatory reaction after pediatric cataract surgery. Am J Ophthalmol. 2006 Mar;141(3):433-7. doi: 10.1016/j.ajo.2005.08.020.
PubMed 16490487Wilson ME Jr, Trivedi RH. Low molecular-weight heparin in the intraocular irrigating solution in pediatric cataract and intraocular lens surgery. Am J Ophthalmol. 2006 Mar;141(3):537-8. doi: 10.1016/j.ajo.2005.11.012. No abstract available.
PubMed 16490502Vasavada VA, Praveen MR, Shah SK, Trivedi RH, Vasavada AR. Anti-inflammatory effect of low-molecular-weight heparin in pediatric cataract surgery: a randomized clinical trial. Am J Ophthalmol. 2012 Aug;154(2):252-258.e4. doi: 10.1016/j.ajo.2012.02.021. Epub 2012 Apr 27.
PubMed 22541652
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery
- ClinicalTrials.gov ID
- NCT00986076
- Acronym / sponsor ID
- 08-010
- Conditions
- Inflammation
- Keywords
- Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Sep 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.
The purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (IOL) implantation.
Detailed description
Despite advances in cataract surgery in children, postoperative inflammation is a significant complication following pediatric cataract surgery. Any drug that prevents or decreases this inflammation would be beneficial.
Heparin has anti-inflammatory and antiproliferative effects as well as anticoagulant properties. Several studies on animal and adult human eyes show that adding heparin to the irrigating solution during cataract surgery results in less disturbance of the blood-aqueous barrier and helps prevent posterior capsule opacification (PCO).
A prospective, randomized, controlled and masked study is mandatory to evaluate the anti-inflammatory effect of Low-molecular weight Heparin for pediatric cataract surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin infusion | Experimental | Drug: EnoxaparinCongenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin |
| Balanced Salt Solution Infusion | Placebo comparator | Drug: Balanced Salt SolutionCongenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (0-15 years) with congenital cataract scheduled for surgery with IOL implantation and informed consent from the parents/legal guardian
Key exclusion criteria (2 listed)
- Preoperative: Associated ocular anomalies (uveitis, microphthalmos, persistent fetal vasculature, aniridia, glaucoma, iris coloboma), traumatic cataract
- Intraoperative: Inability to implant IOL in the capsular bag, intraoperative complications- iris trauma, vitreous disturbance, descemet's detachment
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 |
|---|---|---|
| EnoxaparinAlso: Clexane(Aventis)Enoxaparin 40 mg / 500 ml in Balanced Salt Solution | Drug | Enoxaparin infusion |
| Balanced Salt SolutionAlso: BSSIntraocular infusion of Balanced Salt solution | Drug | Balanced Salt Solution Infusion |
Primary outcome
Anterior Segment Inflammation
Time frame: 1 week
1 secondary outcome
Anterior Segment inflammation
Time frame: 1 month, 3 months
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 29 Sep 2009.
- Background: PubMed 11777715Kruger A, Amon M, Abela-Formanek C, Schild G, Kolodjaschna J, Schauersberger J. Effect of heparin in the irrigation solution on postoperative inflammation and cellular reaction on the intraocular lens surface. J Cataract Refract Surg. 2002 Jan;28(1):87-92. doi: 10.1016/s0886-3350(01)00861-6.
- Background: PubMed 16490487Rumelt S, Stolovich C, Segal ZI, Rehany U. Intraoperative enoxaparin minimizes inflammatory reaction after pediatric cataract surgery. Am J Ophthalmol. 2006 Mar;141(3):433-7. doi: 10.1016/j.ajo.2005.08.020.
- Background: PubMed 16490502Wilson ME Jr, Trivedi RH. Low molecular-weight heparin in the intraocular irrigating solution in pediatric cataract and intraocular lens surgery. Am J Ophthalmol. 2006 Mar;141(3):537-8. doi: 10.1016/j.ajo.2005.11.012. No abstract available.
- Derived from this study: PubMed 22541652Vasavada VA, Praveen MR, Shah SK, Trivedi RH, Vasavada AR. Anti-inflammatory effect of low-molecular-weight heparin in pediatric cataract surgery: a randomized clinical trial. Am J Ophthalmol. 2012 Aug;154(2):252-258.e4. doi: 10.1016/j.ajo.2012.02.021. 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.
Viraj A Vasavada, MS principal investigator
Iladevi Cataract & 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 Enoxaparin and Balanced Salt Solution in people with Inflammation, 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 1 inclusion and 2 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 29 Sep 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. Some participants in this study may receive a placebo. 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?
Anterior Segment Inflammation (time frame: 1 week). 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 NCT00986076, which also lists 4 linked publications.
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 29 Sep 2009.