Clinical trial NCT02581046: Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts
Official title: Effect of the Timing of Lens-removal Cataract Surgery on Postoperative Complications Rate Among Patients With Bilateral Congenital Cataracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2015-10-20
Enrollment: 61
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
timeFrame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
measure: Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)
timeFrame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
measure: Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)
timeFrame: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Secondary outcomes:
measure: Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
timeFrame: 2 year after surgery
measure: Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification（PCO）
timeFrame: 2 year after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.
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.
citation: 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.