Limbal DermoidNCT03447041
Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation
An observational study of Limbal Dermoid, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality. Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Limbal Dermoid
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Dec 2020
- 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 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: There would include 50 eyes of 50 patients with corneal transplantation (the keratoplasty group) and 15 eyes of 15 normal subjects (the normal group) in this study
Who may be able to join
- Accept the corneal transplantation based on the clinical diagnosis of ocular surface disease;
- more than 7 and less than 60 years old;
- absence of other ocular disorders and no history of eye surgery and other systemic diseases.
Who cannot join
- less than 7 or more than 60 years old;
- with the history of eye surgery and other systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zhongshan Ophthalmic Center, Sun Yat-Sen University,China
This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality.
Read the detailed description
Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. A large proportion of patients, all of whom had epibular dermoids, has amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. However, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. Several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. Although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for LD were relatively less.
50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination. Then the normal group would be covered by the positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.
- Conditions
- Limbal Dermoid
- Keywords
- Keratopathy, Visual Quality, Contrast Sensitivity Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the keratoplasty group | Patients with limbal dermoid who accepted cornea transplantation surgery after 1 year were performed quick CSF from Adaptive Sensory Technology company | |
| the normal group | normal children without ocular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contrast sensitivity function tested by quick CSF in the keratoplasty group
The quick CSF (contrast sensitivity function) tests including AULCSF (the area under the log CSF) and Cutoff SF (Cutoff sensitivity function)
Measured: on 1 year postkeratoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal DermoidStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Jin Yuan, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447041
- Sponsor's protocol ID
- ZOC20171217
- Status last verified
- Nov 2021
- First submitted
- 17 Dec 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhongshan Ophthalmic Center, Sun Yat-Sen University,China
- ClinicalTrials.gov ID
- NCT03447041
- Acronym / sponsor ID
- ZOC20171217
- Conditions
- Limbal Dermoid
- Keywords
- Keratopathy, Visual Quality, Contrast Sensitivity Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Feb 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.
This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality.
Detailed description
Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. A large proportion of patients, all of whom had epibular dermoids, has amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. However, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. Several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. Although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for LD were relatively less.
50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination. Then the normal group would be covered by the positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the keratoplasty group | – | –Patients with limbal dermoid who accepted cornea transplantation surgery after 1 year were performed quick CSF from Adaptive Sensory Technology company |
| the normal group | – | –normal children without ocular disease |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- There would include 50 eyes of 50 patients with corneal transplantation (the keratoplasty group) and 15 eyes of 15 normal subjects (the normal group) in this study
Key inclusion criteria (3 listed)
- Accept the corneal transplantation based on the clinical diagnosis of ocular surface disease;
- more than 7 and less than 60 years old;
- absence of other ocular disorders and no history of eye surgery and other systemic diseases.
Key exclusion criteria (2 listed)
- less than 7 or more than 60 years old;
- with the history of eye surgery and other systemic diseases.
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
The contrast sensitivity function tested by quick CSF in the keratoplasty group
Time frame: on 1 year postkeratoplasty
The quick CSF (contrast sensitivity function) tests including AULCSF (the area under the log CSF) and Cutoff SF (Cutoff sensitivity function)
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 7 Dec 2021.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available
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.
Jin Yuan study chair
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 Limbal Dermoid, run by Zhongshan Ophthalmic Center, 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 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 7 Dec 2021. 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?
The contrast sensitivity function tested by quick CSF in the keratoplasty group (time frame: on 1 year postkeratoplasty). 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 7 Dec 2021.