- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02581046
Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts
Effect of the Timing of Lens-removal Cataract Surgery on Postoperative Complications Rate Among Patients With Bilateral Congenital Cataracts
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510060
- Zhognshan Ophthalmic Center, Sun Yat-sen University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 3 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.
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모든 환자는 수술 중 결막하 덱사메타손(2 mg)을 투여받았고 모든 수술은 전신마취 하에 시행되었다.
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.
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실험적: 6 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..
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모든 환자는 수술 중 결막하 덱사메타손(2 mg)을 투여받았고 모든 수술은 전신마취 하에 시행되었다.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
기간: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)
기간: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)
기간: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
기간: 2 year after surgery
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2 year after surgery
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Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification(PCO)
기간: 2 year after surgery
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2 year after surgery
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCPMOH2010-China7
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