CataractNCT02765230
An Interocular Comparative Study of Unilateral Cataract
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Cataract
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2016
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: All of the registered children of CCPMOH were diagnosed by anterior segmental photography to confirm the morphology, location, and degree of cataract after pupil dilation. Fifty-three pediatric patients (53 cataract eyes and 53 contralateral normal eyes) with uncomplicated unilateral total cataract were selected 3 months after surgery from the CCPMOH.
Who may be able to join
- Children with uncomplicated surgeries
- Children who were younger than 10 years old
- Children with unilateral total cataract
Who cannot join
- Premature birth
- Microphthalmia
- Micro-or Megalocornea
- Keratoconus
- Glaucoma
- Traumatic or complicated cataracts
- Vitreous and retinal diseases
- Any previous surgeries
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study
The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.
Read the detailed description
Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract.
Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.
- Conditions
- Cataract
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam
The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.
Measured: Baseline
Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards
The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765230
- Sponsor's protocol ID
- CCPMOH2016-China-3
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hutcheson KA. Application of new ophthalmic technology in the pediatric patient. Curr Opin Ophthalmol. 2007 Sep;18(5):384-91. doi: 10.1097/ICU.0b013e328244e07e.
PubMed 17700231Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
PubMed 22921386Long E, Chen J, Liu Z, Lin Z, Cao Q, Zhang X, Li X, Luo L, Lin H, Chen W, Liu Y. Interocular anatomical and visual functional differences in pediatric patients with unilateral cataracts. BMC Ophthalmol. 2016 Nov 3;16(1):192. doi: 10.1186/s12886-016-0371-5.
PubMed 27809833
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02765230
- Acronym / sponsor ID
- CCPMOH2016-China-3
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- 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 purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.
Detailed description
Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract.
Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All of the registered children of CCPMOH were diagnosed by anterior segmental photography to confirm the morphology, location, and degree of cataract after pupil dilation. Fifty-three pediatric patients (53 cataract eyes and 53 contralateral normal eyes) with uncomplicated unilateral total cataract were selected 3 months after surgery from the CCPMOH.
Key inclusion criteria (3 listed)
- Children with uncomplicated surgeries
- Children who were younger than 10 years old
- Children with unilateral total cataract
Key exclusion criteria (8 listed)
- Premature birth
- Microphthalmia
- Micro-or Megalocornea
- Keratoconus
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam
Time frame: Baseline
The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.
Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards
Time frame: Baseline
The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).
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 6 May 2016.
- Background: PubMed 17700231Hutcheson KA. Application of new ophthalmic technology in the pediatric patient. Curr Opin Ophthalmol. 2007 Sep;18(5):384-91. doi: 10.1097/ICU.0b013e328244e07e.
- Background: PubMed 22921386Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
- Derived from this study: PubMed 27809833Long E, Chen J, Liu Z, Lin Z, Cao Q, Zhang X, Li X, Luo L, Lin H, Chen W, Liu Y. Interocular anatomical and visual functional differences in pediatric patients with unilateral cataracts. BMC Ophthalmol. 2016 Nov 3;16(1):192. doi: 10.1186/s12886-016-0371-5.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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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.
Haotian Lin, M.D., Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D. study director
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 Cataract, 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 3 inclusion and 8 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 6 May 2016. 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?
Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765230, which also lists 3 linked publications.
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 6 May 2016.