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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients
Subconjunctival dexamethasone and general anesthesia
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 month surgical group

6 month surgical group

Arm Description

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..

Outcomes

Primary Outcome Measures

Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)
Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)

Secondary Outcome Measures

Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification(PCO)

Full Information

First Posted
October 16, 2015
Last Updated
October 18, 2015
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
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1. Study Identification

Unique Protocol Identification Number
NCT02581046
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 month surgical group
Arm Type
Experimental
Arm Description
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.
Arm Title
6 month surgical group
Arm Type
Experimental
Arm Description
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..
Intervention Type
Procedure
Intervention Name(s)
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Subconjunctival dexamethasone and general anesthesia
Intervention Description
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Primary Outcome Measure Information:
Title
Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
Time Frame
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Title
Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)
Time Frame
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Title
Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)
Time Frame
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
Secondary Outcome Measure Information:
Title
Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
Time Frame
2 year after surgery
Title
Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification(PCO)
Time Frame
2 year after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weirong Chen, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15899463
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.
Results Reference
background
PubMed Identifier
25325868
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.
Results Reference
background
PubMed Identifier
24138041
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.
Results Reference
background
PubMed Identifier
25892047
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.
Results Reference
background
PubMed Identifier
22411128
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.
Results Reference
background
PubMed Identifier
23237753
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.
Results Reference
background
PubMed Identifier
25915009
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.
Results Reference
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Links:
URL
http://www.gzzoc.com/
Description
Home page of Zhongshan Ophthalmic Center
URL
http://www.cnccclub.com/
Description
Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)

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

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