Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

18. oktober 2015 opdateret af: Haotian Lin, Sun Yat-sen University

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Zhognshan Ophthalmic Center, Sun Yat-sen University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 3 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 3 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.
Medicin: Subkonjunktival dexamethason og generel anæstesi
Alle patienter fik subkonjunktival dexamethason (2 mg) under operationen, og alle operationer blev udført under generel anæstesi.
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.
Eksperimentel: 6 month surgical group
Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..
Medicin: Subkonjunktival dexamethason og generel anæstesi
Alle patienter fik subkonjunktival dexamethason (2 mg) under operationen, og alle operationer blev udført under generel anæstesi.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)
Tidsramme: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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)
Tidsramme: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
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)
Tidsramme: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month
during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month

Sekundære resultatmål

Resultatmål
Tidsramme
Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma
Tidsramme: 2 year after surgery
2 year after surgery
Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification（PCO）
Tidsramme: 2 year after surgery
2 year after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Samarbejdspartnere

Ministry of Health, China

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

16. oktober 2015

Først indsendt, der opfyldte QC-kriterier

18. oktober 2015

Først opslået (Skøn)

20. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCPMOH2010-China7

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Subkonjunktival dexamethason og generel anæstesi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner