Clinical trial NCT03447041: Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation
Official title: Zhongshan Ophthalmic Center, Sun Yat-Sen University,China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limbal Dermoid
Keywords: Keratopathy
Visual Quality
Contrast Sensitivity Function
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The contrast sensitivity function tested by quick CSF in the keratoplasty group
timeFrame: on 1 year postkeratoplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Jin Yuan
role: STUDY_CHAIR
References: