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

NCT ID: NCT03447041

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-12-30

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.

Conditions

Limbal Dermoid

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

the keratoplasty group

Patients with limbal dermoid who accepted cornea transplantation surgery after 1 year were performed quick CSF from Adaptive Sensory Technology company

No interventions assigned to this group

the normal group

normal children without ocular disease

No interventions assigned to this group

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Yuan

Yuanjin PI group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Yuan

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Opthalmic Center

Guangzhou, Guangdong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZOC20171217

Identifier Type: -

Identifier Source: org_study_id