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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL

Conditions
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Age-related Cataract

Intervention / Treatment
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* Drug: Hylo-Comod eye drop
* Drug: Tears Naturale Forte eye drop


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hylo-Comod<br>The patients used Hylo-Comod eye drop after phaco+IOL in this group. | Drug: Hylo-Comod eye drop<br>* The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL<br>* Other names: 0.3% tobramycin/dexamethasone (TobraDex, Alcon);|
| Experimental: Tears Naturale Forte<br>The patients used Tears Naturale Forte eye drop after phaco+IOL in this group. | Drug: Tears Naturale Forte eye drop<br>* The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL<br>* Other names: 0.3% tobramycin/dexamethasone (TobraDex, Alcon);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale of Schirmer I test |  | up to 2 months after surgery | 
| scale of corneal fluorescein staining |  | up to 2 months after surgery | 
| scale of noninvasive tear breakup time |  | up to 2 months after surgery | 
| questionnaire of ocular surface disease index |  | up to 2 months after surgery | 
| scale of central corneal sensitivity |  | up to 2 months after surgery | 
| scale of tear meniscus height |  | up to 2 months after surgery | 
| concentration of Interleukin-1α |  | up to 2 months after surgery | 
| concentration of tumor necrosis factor-α |  | up to 2 months after surgery | 
| concentration of nerve growth factor |  | up to 2 months after surgery | 
| concentration of interferon-γ |  | up to 2 months after surgery | 
| concentration of transforming growth factor-β1 |  | up to 2 months after surgery | 
| concentration of matrix metalloproteinase-9 |  | up to 2 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Inflammatory Mediators and Ocular Surface Changes |  | up to 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age-related cataract, Holy-Comod, Tears Naturale Forte, phacoemulsification, inflammatory mediators