- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778086
Iridocorneal Angle and Anterior Segment Structure in Eyes of Children With Cataract (ACA)
December 14, 2018 updated by: Yune Zhao, Wenzhou Medical University
Iridocorneal Angle and Anterior Segment Structure in Pediatric Cataract
The aim of this study is to evaluate the morphology of iridocorneal angle and anterior segment structure in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma.
The investigators included children with cataract planning to have cataract surgery in our institute.
For analysis, one eye was randomly selected in a case of bilateral cataract via a random table, forming the "bilateral cataract" group; the cataractous eyes in cases of unilateral cataract composed the "unilateral cataract" group and the fellow non-cataractous eyes made up the "control" group.
Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations.
The investigators recorded age at surgery, gender and relevant ocular and systemic histories.
All patients underwent slit lamp biomicroscopy, dilated fundus examination and cycloplegic retinoscopy.
In patients with good cooperation, The investigators obtained the axial length (AL) using IOL-Master 500 and the intraocular pressure (IOP) with a non-contact tonometer.
In young patients with poor cooperation, the investigators measured the AL with a contact A-scan, the central corneal thickness (CCD) value with a handheld pachymeter and the IOP using a handheld tonometer under sedation.
With a contact A-scan, the AL measurement was repeated 10 times by the same examiner and the mean value was analyzed.
Corneal diameter was measured with a caliper in the operating room before cataract surgery.
Under general anesthesia, a pediatric surgeon (YEZ) evaluated the iridocorneal angle with an indirect goniolens under the operating microscope.
A gentle tilting of the goniolens was allowed to obtain a better view of the angle.
Another experienced pediatric ophthalmologist (DDW) double checked the video recordings and graded the details of iridocorneal angle according to the Shaffer and Spaeth classification system and standard methods reported.
The angle width was defined as follows: grade 0, a closed angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4, the widest angle with ciliary body band (CBB) visible.
The iris insertion and pigmentation of the posterior trabecular meshwork were classified according to the Spaeth classification system.
The iris insertion was defined as follows: A, anterior to Schwalbe's line; B, between Schwalbe's line and scleral spur; C, scleral spur visible; D, deep with ciliary body visible; E, extremely deep with > 1 mm ciliary body band.
The pigmentation of trabecular meshwork was defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment; 3, moderate pigment; 4, intense pigment.
The number of iris process was defined as follows: 0, none; 1, minimal; 2, moderate; 3, marked.
The width of CBB was graded according to the classification proposed by Tawara et al and defined as follows: invisible, the CBB could not be seen at all; very narrow, the CBB was narrower than the scleral spur; normal, the CBB was wider than the scleral spur.
The normality of variables was tested using Kolmogorov-Smirnov test.
Continuous variables are presented as mean±standard deviation or median (interquartile range) based on the normality of variables, and categorical variables are presented as frequencies and percentages.
One-way ANOVA or Kruskal-Wallis test was used for overall comparison, and Dunnett test or Kruskal-Wallis One-way ANOVA was used for paired-comparison of variables between groups where appropriate.
Mann-Whitney test was used for further subgroup comparison.
A P value less than 0.05 was considered statistically significant.
All statistical analyses were performed using SPSS version 21.0 (SPSS Inc, Chicago, Illinois, USA).
Study Overview
Study Type
Observational
Enrollment (Actual)
100
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
1 year to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants included eyes of children with unilateral or bilateral cataract.
Description
Inclusion Criteria:
- children with cataract
Exclusion Criteria:
- a history of ocular trauma
- a history of intraocular surgery
- preoperative glaucoma
- steroid use before surgery
- a history of maternal rubella syndrome
- chronic anterior uveitis
- persistent fetal vasculature
- ocular anomalies associated with an increased risk of glaucoma
- unable to complete examinations.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cataractous eyes
eyes of children with unilateral or bilateral cataract
|
gonioscopic observation and grading of iridocorneal angle
|
fellow eyes
fellow eyes of children with unilateral cataract
|
gonioscopic observation and grading of iridocorneal angle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Width of angle
Time Frame: 2016-06-01 to 2018-06-01
|
The angle width was defined as follows: grade 0, a closed angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4, the widest angle with ciliary body band (CBB) visible
|
2016-06-01 to 2018-06-01
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Width of ciliary body band
Time Frame: 2016-06-01 to 2018-06-01
|
The width of ciliary body band(CBB) is defined as follows: invisible, the CBB could not be seen at all; very narrow, the CBB is narrower than the scleral spur; normal, the CBB is wider than the scleral spur
|
2016-06-01 to 2018-06-01
|
The number of iris processes
Time Frame: 2016-06-01 to 2018-06-01
|
The number of iris process is defined as follows: 0, none; 1, minimal; 2, moderate; 3, marked
|
2016-06-01 to 2018-06-01
|
Trabecular meshwork pigmentation
Time Frame: 2016-06-01 to 2018-06-01
|
The pigmentation of trabecular meshwork is defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment
|
2016-06-01 to 2018-06-01
|
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)
June 1, 2016
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
December 6, 2018
First Submitted That Met QC Criteria
December 14, 2018
First Posted (ACTUAL)
December 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 14, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACA_LZL_HZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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