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

NCT02581046 | Completed DMC

• 1 other identifier: CCPMOH2010-China7
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma

  2 year after surgery

• Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification（PCO）

  2 year after surgery

Study Arms (2)

3 month surgical group

EXPERIMENTAL

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

Procedure: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients; Drug: Subconjunctival dexamethasone and general anesthesia

6 month surgical group

EXPERIMENTAL

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

Procedure: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients; Drug: Subconjunctival dexamethasone and general anesthesia

Interventions

Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients PROCEDURE

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.

3 month surgical group

Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients PROCEDURE

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.

6 month surgical group

Subconjunctival dexamethasone and general anesthesia DRUG

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

3 month surgical group; 6 month surgical group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children not identified with congenital cataract
• Have not signed consent form
• Be not able to be followed

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (7)

• 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.

  PMID: 15899463 BACKGROUND

• 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.

  PMID: 25325868 BACKGROUND

• 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.

  PMID: 24138041 BACKGROUND

• 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.

  PMID: 25892047 BACKGROUND

• 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.

  PMID: 22411128 BACKGROUND

• 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.

  PMID: 23237753 BACKGROUND

• 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.

  PMID: 25915009 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cataract

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Haotian Lin, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yizhi Liu, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

• Weirong Chen, M.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 20, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

CN (1)