The Effects of Primary Pterygium on Contrast Sensitivity Preoperatively and Postoperatively

NCT03406390 | Unknown

• 1 other identifier: 2017011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pterygium is the growth of conjunctival tissue onto the cornea, usually from the nasal quadrant of the cornea.Visual acuity may be reduced due to direct invasion of the visual axis or astigmatism induced by the pterygium. Contrast sensitivity measures two variables, size, and contrast which could comprehensively reflect the visual quality of the primary pterygium patients. In this study, we would investigate the the effects of primary pterygium on contrast sensitivity preoperatively and on the 1st, 3rd and 6th month postoperatively, moreover, the related parameters on the contrast sensitivity in the primary pterygium patients would be analyzed.

Conditions

Primary Pterygium

Keywords

contrast sensitivity; Pterygium

Outcome Measures

Primary Outcomes (1)

• The contrast sensitivity function tested by quick CSF of the Primary Pterygium patients preoperatively

  The contrast sensitivity function of the Primary Pterygium patients is lower than the normal people by qucik CSF method

  Preoperatively

Secondary Outcomes (1)

• The contrast sensitivity function tested by quick CSF of the Primary Pterygium patients postoperatively

  1st, 3rd and 6th month postoperatively

Study Arms (1)

primary pterygium

Observe the contrast sensitivity of primary pterygium patients and healthy control by quick CSF methods, and the pterygium group would achieve the pterygium surgery by the same surgeon (Jin Yuan) and then be performed the contrast sensitivity test on the 1st, 3rd and 6th month postoperatively.

Procedure: Pterygium surgery

Interventions

Pterygium surgery PROCEDURE

The patients were anesthetized with subconjunctival injection.Symblepharon was released and fibrotic tissue was extensively dissected to expose the sclera and corneal stroma. The subconjunctival fibrovascular tissue, including Tenon's capsule, were thoroughly removed using scissors from the sclera and medial rectus muscle at the area of the superior and inferior fornices and the nasal caruncle. A cryopreserved human amniotic membrane (Zhongshan Ophthalmic Center, China) was then placed on the entire exposed bare sclera with the epithelial side facing upward, and secured with 10-0 nylon sutures.

primary pterygium

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

There would have two groups included in our study, which are 40 patients of primary pterygium group and 20 healthy volunteers.

You may qualify if:

• Clinical diagnosis of the primary pterygium;
• More than 18 and less than 60 years old;
• or better logMAR BCVA;
• The absence of other ocular disorders and no history of eye surgery and other systemic diseases.

You may not qualify if:

• Clinical diagnosis of recurrent pterygium or accompanied with other ocular diseases;
• less than 18 or more than 60 years old;
• The logMAR BCVA is less than 0.0;
• With the history of eye surgery and other systemic diseases.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Opthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Jin Yuan, Professor

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Jing Zhong, Doctor

CONTACT

13527841235; zhongjing_90@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: January 23, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)