Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts
NCT ID: NCT02581046
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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Several previous studies claimed that ideally cataracts should be removed before 3 months of age, while the result of recent researches shows that too early intervention for cataract surgery seems aggressive and would cause serious complications, which might cause poor long-term visual outcomes. Therefore, in order to control childhood blindness and severe visual impairment in China, it is of great importance to ensure that pediatric patients with cataract could have good timing of surgery, postoperative rigorous supervision, accurate optical rehabilitation and comprehensive treatment of amblyopia.
In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months, 18months and 24months after cataract surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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3 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients
The surgical timing of phacoemulsification is perform at the age of 3 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
6 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients
The surgical timing of phacoemulsification is perform at the age of 6 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Interventions
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Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients
The surgical timing of phacoemulsification is perform at the age of 3 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients
The surgical timing of phacoemulsification is perform at the age of 6 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Eligibility Criteria
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Inclusion Criteria
* No more than 3 month old
* Have signed a consent form
* Can be followed
Exclusion Criteria
* Have not signed consent form
* Be not able to be followed
3 Months
ALL
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center
Principal Investigators
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Haotian Lin, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D.
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Zetterstrom C, Lundvall A, Kugelberg M. Cataracts in children. J Cataract Refract Surg. 2005 Apr;31(4):824-40. doi: 10.1016/j.jcrs.2005.01.012.
Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192.
Mansouri B, Stacy RC, Kruger J, Cestari DM. Deprivation amblyopia and congenital hereditary cataract. Semin Ophthalmol. 2013 Sep-Nov;28(5-6):321-6. doi: 10.3109/08820538.2013.825289.
Lenhart PD, Courtright P, Wilson ME, Lewallen S, Taylor DS, Ventura MC, Bowman R, Woodward L, Ditta LC, Kruger S, Haddad D, El Shakankiri N, Rai SK, Bailey T, Lambert SR. Global challenges in the management of congenital cataract: proceedings of the 4th International Congenital Cataract Symposium held on March 7, 2014, New York, New York. J AAPOS. 2015 Apr;19(2):e1-8. doi: 10.1016/j.jaapos.2015.01.013.
Magli A, Forte R, Rombetto L. Long-term outcome of primary versus secondary intraocular lens implantation after simultaneous removal of bilateral congenital cataract. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):309-14. doi: 10.1007/s00417-012-1979-7. Epub 2012 Mar 14.
Young MP, Heidary G, VanderVeen DK. Relationship between the timing of cataract surgery and development of nystagmus in patients with bilateral infantile cataracts. J AAPOS. 2012 Dec;16(6):554-7. doi: 10.1016/j.jaapos.2012.08.008.
Bayoumi NH. Surgical Management of Glaucoma After Congenital Cataract Surgery. J Pediatr Ophthalmol Strabismus. 2015 Jul-Aug;52(4):213-20. doi: 10.3928/01913913-20150414-11. Epub 2015 Apr 17.
Related Links
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Home page of Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2010-China7
Identifier Type: -
Identifier Source: org_study_id
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