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Visual Quality and Contrast Sensitivity Function After Corneal Transplantation

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ClinicalTrials.gov Identifier: NCT03447041
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary:
This study is to inquiry the contrast sensitivity function in the 50 eyes of keratoplasty patients with quick contrast sensitivity function (quick CSF), as well the relationship between visual quality.

Condition or disease Intervention/treatment
Keratopathy Procedure: keratoplasty

Detailed Description:

Keratoplasty, also known as corneal transplantation, is a surgical procedure in which a damaged or diseased cornea is replaced entirely (penetrating keratoplasty) or partially (lamellar keratoplasty) by a donated corneal graft. The postoperative refractive error, post-keratoplasty astigmatism particularly is one of the most important factors that contribute to poor visual outcome following successful keratoplasty. This study is to inquiry the contrast sensitivity function in the keratoplasty patients with quick contrast sensitivity function (quick CSF), as well the relationship between visual quality.

50 eyes of 50 keratopathy patients 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Zhongshan Ophthalmic Center, Sun Yat-Sen University,China
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
the keratoplasty group
Patients who accepted cornea transplantation surgery after 1 year were performed quick CSF from Adaptive Sensory Technology company
Procedure: keratoplasty
  1. Mark the center of the host cornea with a Sinskey hook. Use calipers to measure the corneal diameter to determine the appropriate size for donor trephine.
  2. Trephine the donor tissue, typically aiming for 0.25 or 0.5 mm larger than the planned host trephination.
  3. Trephinate the host cornea to approximately 90% depth.
  4. Create a paracentesis in the trephination groove or the corneal periphery, and inject Healon into the anterior chamber to preserve anterior chamber depth and stability.
  5. After using a blade to enter the eye through the trephination groove, resect the host cornea tissue using curved corneal scissors.
  6. Secure the donor graft to the host corneal tissue using interrupted and/or running 10-0 nylon sutures.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447041


Contacts
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Contact: Jing Zhong, Doctor 13527841235 zhongjing_90@163.com
Contact: Jin Yuan, Professor 2087333391 yuanjincornea@126.com

Locations
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China, Guangdong
Zhongshan Opthalmic Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jing Zhong, Doctor    13527841235    zhongjing_90@163.com   
Principal Investigator: Jin Yuan, Professor         
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Study Chair: Jin Yuan Zhongshan Ophthalmic Center, Sun Yat-sen University
  Study Documents (Full-Text)

Documents provided by Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University:

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Responsible Party: Jin Yuan, Yuanjin PI group, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03447041     History of Changes
Other Study ID Numbers: ZOC20171217
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD and related data dictionaries available
Supporting Materials: Study Protocol
Time Frame: starting in January 2020
Access Criteria: The Visual Quality and Contrast Sensitivity Function of the keratoplasty group and the normal group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University:
Keratopathy
Visual Quality
Contrast Sensitivity Function