Congenital Cataract Polar PosteriorNCT05207007
Visual Function in Pediatric Patients With Posterior Lens Opacities
An observational study of Congenital Cataract Polar Posterior, run by Sun Yat-sen University at 1 site in China.
Trial summary
Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Congenital Cataract Polar Posterior
- What is being tested?
- Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2020to 29 Aug 2021
- 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 3 to 14 years
- All sexes
- Child
Study population: Patients with congenital posterior polar cataracts or posterior lenticonus who need cataract surgery at the Zhongshan Ophthalmic Center, Sun Yat-sen University in China were included. The patients who had relevant ocular disease other than congenital cataract or could not cooperate to the examinations were excluded. The indication for surgery in all patients was significantly deteriorated visual function and amblyopia treatment failure (decline in CDVA to 20/80 or worse). The study adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from each subject.
Who may be able to join
- Children with posterior polar cataracts or posterior lenticonus who need cataract surgery
- Aged 3-14 years
- Have signed a consent form
- Can be followed
Who cannot join
- Have relevant ocular disease other than congenital cataract
- Could not cooperate to the examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus
Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.
Read the detailed description
Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.
In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.
- Conditions
- Congenital Cataract Polar Posterior
- Being tested
- Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation
- Keywords
- visual function, posterior polar cataracts, posterior lenticonus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantationProcedure or surgery
Phacomulsification lens removal cataract surgery with IOL implantation in both two groups
| Study group | Role | What they receive |
|---|---|---|
| posterior polar cataracts | Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients.
Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia. Receives: Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation | |
| posterior lenticonus | Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients.
Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia. Receives: Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (BCVA)
Visual acuity (BCVA) measured by ETDRS chart after surgery
Measured: 6 month after surgery
Stereoacuity
Stereoacuity measured at 40 cm using the Randot stereotests
Measured: 6 month after surgery
modulation transfer function (MTF)
MTF measured with the Optical Quality Analysis System
Measured: 6 month after surgery
monochromatic aberrations
monochromatic aberrations measured by the iTrace Dynamic Laser Refraction
Measured: 6 month after surgery
Secondary outcomes (6)
Location of the cataracts
divided into central, paracentral, and peripheral
Measured: before surgery
size of lens lesion
measured by image J
Measured: before surgery
Visual acuity (BCVA)
Visual acuity (BCVA) measured by ETDRS chart before surgery
Measured: before surgery
Stereoacuity
Stereoacuity measured at 40 cm using the Randot stereotests
Measured: before surgery
modulation transfer function (MTF)
MTF measured with the Optical Quality Analysis System
Measured: before surgery
monochromatic aberrations
monochromatic aberrations measured by the iTrace Dynamic Laser Refraction system
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start4 Jan 2020
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cataract Polar PosteriorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Weirong Chen, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207007
- Sponsor's protocol ID
- CCPMOH2020-China20
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus
- ClinicalTrials.gov ID
- NCT05207007
- Acronym / sponsor ID
- CCPMOH2020-China20
- Conditions
- Congenital Cataract Polar Posterior
- Keywords
- visual function, posterior polar cataracts, posterior lenticonus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 25 Jan 2022 (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.
Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.
Detailed description
Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.
In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior polar cataracts | – | Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantationPhacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia. |
| posterior lenticonus | – | Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantationPhacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with congenital posterior polar cataracts or posterior lenticonus who need cataract surgery at the Zhongshan Ophthalmic Center, Sun Yat-sen University in China were included. The patients who had relevant ocular disease other than congenital cataract or could not cooperate to the examinations were excluded. The indication for surgery in all patients was significantly deteriorated visual function and amblyopia treatment failure (decline in CDVA to 20/80 or worse). The study adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from each subject.
Key inclusion criteria (4 listed)
- Children with posterior polar cataracts or posterior lenticonus who need cataract surgery
- Aged 3-14 years
- Have signed a consent form
- Can be followed
Key exclusion criteria (2 listed)
- Have relevant ocular disease other than congenital cataract
- Could not cooperate to the examinations
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 |
|---|---|---|
| Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantationPhacomulsification lens removal cataract surgery with IOL implantation in both two groups | Procedure or surgery | posterior lenticonus, posterior polar cataracts |
Primary outcome
Visual acuity (BCVA)
Time frame: 6 month after surgery
Visual acuity (BCVA) measured by ETDRS chart after surgery
Stereoacuity
Time frame: 6 month after surgery
Stereoacuity measured at 40 cm using the Randot stereotests
modulation transfer function (MTF)
Time frame: 6 month after surgery
MTF measured with the Optical Quality Analysis System
monochromatic aberrations
Time frame: 6 month after surgery
monochromatic aberrations measured by the iTrace Dynamic Laser Refraction
6 secondary outcomes
Location of the cataracts
Time frame: before surgery
size of lens lesion
Time frame: before surgery
Visual acuity (BCVA)
Time frame: before surgery
Stereoacuity
Time frame: before surgery
modulation transfer function (MTF)
Time frame: before surgery
monochromatic aberrations
Time frame: before surgery
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 25 Jan 2022.
- Individual participant dataSharing planned: No
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.
Weirong Chen, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cataract Polar Posterior, run by Sun Yat-sen University at 1 site in China.
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 4 inclusion and 2 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Visual acuity (BCVA) (time frame: 6 month after surgery). The study lists 4 primary outcomes in all. 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 25 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.