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

Completed

• Conditions: Limbal Dermoid

• Registration Number: NCT03447041
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2018-02-24
• Study First Posted: 2018-02-27
• Study Start: 2018-03-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The contrast sensitivity function tested by quick CSF in the keratoplasty group	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)

Trial Locations

Locations (1)

Zhongshan Opthalmic Center; 🇨🇳 Guangzhou, Guangdong, China