Congenital CataractACANCT03778086
Iridocorneal Angle and Anterior Segment Structure in Eyes of Children With Cataract
An observational study of Congenital Cataract, run by Wenzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- gonioscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Sep 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants included eyes of children with unilateral or bilateral cataract.
Who may be able to join
- children with cataract
Who cannot join
- 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
Show all 9Show fewer
- persistent fetal vasculature
- ocular anomalies associated with an increased risk of glaucoma
- unable to complete examinations.
About this study
Official title: 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).
- Conditions
- Congenital Cataract
- Being tested
- gonioscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gonioscopyProcedure or surgery
gonioscopic observation and grading of iridocorneal angle
| Study group | Role | What they receive |
|---|---|---|
| cataractous eyes | eyes of children with unilateral or bilateral cataract Receives: Procedure: gonioscopy | |
| fellow eyes | fellow eyes of children with unilateral cataract Receives: Procedure: gonioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of angle
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
Measured: 2016-06-01 to 2018-06-01
Secondary outcomes (3)
Width of ciliary body band
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
Measured: 2016-06-01 to 2018-06-01
The number of iris processes
The number of iris process is defined as follows: 0, none; 1, minimal; 2, moderate; 3, marked
Measured: 2016-06-01 to 2018-06-01
Trabecular meshwork pigmentation
The pigmentation of trabecular meshwork is defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment
Measured: 2016-06-01 to 2018-06-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jun 2016
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778086
- Sponsor's protocol ID
- ACA_LZL_HZ
- Acronym
- ACA
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iridocorneal Angle and Anterior Segment Structure in Pediatric Cataract
- ClinicalTrials.gov ID
- NCT03778086
- Acronym / sponsor ID
- ACA / ACA_LZL_HZ
- Conditions
- Congenital Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cataractous eyes | – | Procedure: gonioscopyeyes of children with unilateral or bilateral cataract |
| fellow eyes | – | Procedure: gonioscopyfellow eyes of children with unilateral cataract |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants included eyes of children with unilateral or bilateral cataract.
Key inclusion criteria (1 listed)
- children with cataract
Key exclusion criteria (9 listed)
- a history of ocular trauma
- a history of intraocular surgery
- preoperative glaucoma
- steroid use before surgery
- a history of maternal rubella syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gonioscopygonioscopic observation and grading of iridocorneal angle | Procedure or surgery | cataractous eyes, fellow eyes |
Primary outcome
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
3 secondary outcomes
Width of ciliary body band
Time frame: 2016-06-01 to 2018-06-01
The number of iris processes
Time frame: 2016-06-01 to 2018-06-01
Trabecular meshwork pigmentation
Time frame: 2016-06-01 to 2018-06-01
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cataract, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of angle (time frame: 2016-06-01 to 2018-06-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.