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Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL

Primary Purpose

Age-related Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hylo-Comod eye drop
Tears Naturale Forte eye drop
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cataract focused on measuring age-related cataract, Holy-Comod, Tears Naturale Forte, phacoemulsification, inflammatory mediators

Eligibility Criteria

60 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 60-72 years old
  • classification of lens nucleus is LOCS Ⅱ

Exclusion Criteria:

  • patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.

Sites / Locations

  • Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hylo-Comod

Tears Naturale Forte

Arm Description

The patients used Hylo-Comod eye drop after phaco+IOL in this group.

The patients used Tears Naturale Forte eye drop after phaco+IOL in this group.

Outcomes

Primary Outcome Measures

scale of Schirmer I test
scale of corneal fluorescein staining
scale of noninvasive tear breakup time
questionnaire of ocular surface disease index
scale of central corneal sensitivity
scale of tear meniscus height
concentration of Interleukin-1α
concentration of tumor necrosis factor-α
concentration of nerve growth factor
concentration of interferon-γ
concentration of transforming growth factor-β1
concentration of matrix metalloproteinase-9

Secondary Outcome Measures

Correlation Between Inflammatory Mediators and Ocular Surface Changes

Full Information

First Posted
June 26, 2016
Last Updated
November 24, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02817191
Brief Title
Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL
Official Title
Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on ocular surface and tear inflammatory mediators in patients after Phaco+IOL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract
Keywords
age-related cataract, Holy-Comod, Tears Naturale Forte, phacoemulsification, inflammatory mediators

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hylo-Comod
Arm Type
Experimental
Arm Description
The patients used Hylo-Comod eye drop after phaco+IOL in this group.
Arm Title
Tears Naturale Forte
Arm Type
Experimental
Arm Description
The patients used Tears Naturale Forte eye drop after phaco+IOL in this group.
Intervention Type
Drug
Intervention Name(s)
Hylo-Comod eye drop
Other Intervention Name(s)
0.3% tobramycin/dexamethasone (TobraDex, Alcon)
Intervention Description
The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL
Intervention Type
Drug
Intervention Name(s)
Tears Naturale Forte eye drop
Other Intervention Name(s)
0.3% tobramycin/dexamethasone (TobraDex, Alcon)
Intervention Description
The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL
Primary Outcome Measure Information:
Title
scale of Schirmer I test
Time Frame
up to 2 months after surgery
Title
scale of corneal fluorescein staining
Time Frame
up to 2 months after surgery
Title
scale of noninvasive tear breakup time
Time Frame
up to 2 months after surgery
Title
questionnaire of ocular surface disease index
Time Frame
up to 2 months after surgery
Title
scale of central corneal sensitivity
Time Frame
up to 2 months after surgery
Title
scale of tear meniscus height
Time Frame
up to 2 months after surgery
Title
concentration of Interleukin-1α
Time Frame
up to 2 months after surgery
Title
concentration of tumor necrosis factor-α
Time Frame
up to 2 months after surgery
Title
concentration of nerve growth factor
Time Frame
up to 2 months after surgery
Title
concentration of interferon-γ
Time Frame
up to 2 months after surgery
Title
concentration of transforming growth factor-β1
Time Frame
up to 2 months after surgery
Title
concentration of matrix metalloproteinase-9
Time Frame
up to 2 months after surgery
Secondary Outcome Measure Information:
Title
Correlation Between Inflammatory Mediators and Ocular Surface Changes
Time Frame
up to 2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60-72 years old classification of lens nucleus is LOCS Ⅱ Exclusion Criteria: patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHI ZHANG, MD, PhD
Phone
+8613790077756
Email
mike0946@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingwu Zhong, MD, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingwu Zhong, MD,PhD
Phone
+86(898)68628481
Email
zhongxwu@mail.sysu.edu.cn

12. IPD Sharing Statement

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Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL

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