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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin infusion | Experimental | Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin |
|
| Balanced Salt Solution Infusion | Placebo Comparator | Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Enoxaparin 40 mg / 500 ml in Balanced Salt Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Segment Inflammation | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Segment inflammation | 1 month, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viraj A Vasavada, MS | Iladevi Cataract & IOL Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iladevi Cataract & IOL Research Centre | Ahmedabad | Gujarat | 380052 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11777715 | Background | 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. | |
| 16490487 | Background |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| C072670 | Hanks Balanced Salt Solution |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Balanced Salt Solution | Drug | Intraocular infusion of Balanced Salt solution |
|
|
| Rumelt 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. |
| 16490502 | Background | Wilson 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. |
| 22541652 | Derived | Vasavada 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. |
| D002241 |
| Carbohydrates |