- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131114
Glaucoma After Congenital And Infantile Cataract Surgery
April 7, 2020 updated by: Haotian Lin, Sun Yat-sen University
Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care.
Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.
Study Overview
Status
Unknown
Conditions
Detailed Description
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.
Study Type
Observational
Enrollment (Anticipated)
241
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haotian Lin, Ph.D
- Phone Number: +86-020-87333271
- Email: gddlht@aliyun.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Zhongshan Ophthalmic Center
-
Contact:
- Jinghui Wang, Ph.D
- Phone Number: +86-020-87333271
- Email: wangjinghui1106@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2016 was performed.
Description
Inclusion Criteria:
- a diagnosis of congenital/infantile cataracts without any surgical intervention;
- age younger than 10 years;
- cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment
Exclusion Criteria:
- a preoperative IOP above 21 mm Hg;
- the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
- the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of suspected glaucoma/glaucoma after congenital cataracts
Time Frame: 3 years
|
A Kaplan-Meier analysis was used.
|
3 years
|
Risk Factors of suspected glaucoma/glaucoma after congenital cataracts
Time Frame: 3 years
|
Cox regression analysis was assessed
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
December 30, 2019
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
April 9, 2020
Last Update Submitted That Met QC Criteria
April 7, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2016-China-0303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glaucoma
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
-
Bausch & Lomb IncorporatedNicOx Inc.CompletedPrimary Open Angle Glaucoma | Ocular Hypertension | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Sensimed AGCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaFrance
-
Wills EyeOptovueCompletedPrimary Open-angle Glaucoma | Normal Tension Glaucoma | Glaucoma; DrugsUnited States
-
iSTAR MedicalInternational Drug Development InstituteActive, not recruitingGlaucoma, Open-Angle Glaucoma EyeIndia, Panama
-
Dr. Kaweh MansouriEnrolling by invitationGlaucoma, Angle-Closure | Surgery | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma; Drugs | Glaucoma, Pigmentary | Glaucoma Secondary | Glaucoma Open-Angle | Glaucoma Congenital | Glaucoma CapsulareSwitzerland