Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts

Cataract Clinical Trial

Official title:

Effect of the Timing of Lens-removal Cataract Surgery on Postoperative Complications Rate Among Patients With Bilateral Congenital Cataracts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581046
• Other study ID #: CCPMOH2010-China7
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 18, 2015
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Congenital cataract is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and rigorous postoperative supervision for adverse complication. 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 month, 6 month, 9 month, 12 month, 18month and 24month postoperatively.

Description:

Congenital cataract is a priority of Vision 2020: the Right to Sight, the global initiative to reduce the world's burden of avoidable blindness, because it is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and postoperative supervision for adverse complication is also essential. The timing of surgery of childhood cataract depends on the etiology and on the degree of visual interference. Severe bilateral cataracts with significant obstruction of the visual axis must be treated and surgery is recommended as soon as possible after discovery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Children diagnosis with bilateral congenital cataract for entire lens without other ocular abnormality

• No more than 3 month old

• Have signed a consent form

• Can be followed

Exclusion Criteria:

• Children not identified with congenital cataract

• Have not signed consent form

• Be not able to be followed

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Postoperative Complications

Intervention

Procedure:
• 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.

Drug:
• Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Zetterström C, Lundvall A, Kugelberg M. Cataracts in children. J Cataract Refract Surg. 2005 Apr;31(4):824-40. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)		during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month	No
Primary	Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)		during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month	No
Primary	Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)		during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month	No
Secondary	Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma		2 year after surgery	No
Secondary	Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification(PCO)		2 year after surgery	No

External Links

•   Home page of Zhongshan Ophthalmic Center
•   Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)