Cataract Clinical Trial
Official title:
Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
Verified date | September 2015 |
Source | Democritus University of Thrace |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
Primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale Exclusion Criteria: 1. Endothelial cell count less than 1900, 2. Glaucoma, 3. IOP-lowering medications, 4. Former incisional surgery, 5. Former diagnosis of corneal disease, 6. Diabetes or autoimmune diseases 7. Former diagnosis of dry eye disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | Eye Institute Of thrace | Alexandroupolis | Evros |
Lead Sponsor | Collaborator |
---|---|
Democritus University of Thrace |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Foreign body sensation | Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day | 1 month postoperatively | No |
Secondary | Ocular Redness | Ocular redness will be assessed by means of a validated photographic chart | 7 days postoperatively | No |
Secondary | Corneal Sensitivity | Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day | 1 month postoperatively | No |
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