Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation

November 22, 2021 updated by: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhongshan Opthalmic Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • less than 7 or more than 60 years old;
  • with the history of eye surgery and other systemic diseases.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
on 1 year postkeratoplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZOC20171217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

There is a plan to make IPD and related data dictionaries available

IPD Sharing Time Frame

Starting in March 2018

IPD Sharing Access Criteria

The Visual Quality and Contrast Sensitivity Function of the keratoplasty group and the normal group

IPD Sharing Supporting Information Type

  • Study Protocol

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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