Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Foreign body sensation
Study Overview
Brief Summary
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.
Detailed Description
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group (who will receive Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Endothelial cell count less than 1900,
- •IOP-lowering medications,
- •Former incisional surgery,
- •Former diagnosis of corneal disease,
- •Diabetes or autoimmune diseases
- •Former diagnosis of dry eye disease
Arms & Interventions
Systane ultra group
Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.
Intervention: Systane Ultra (Drug)
Control group
Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]
Intervention: tobradex quid (Standard) (Drug)
Outcomes
Primary Outcomes
Foreign body sensation
Time Frame: 1 month postoperatively
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
Secondary Outcomes
- Corneal Sensitivity(1 month postoperatively)
- Ocular Redness(7 days postoperatively)
Investigators
Georgios Labiris
Assistant Professor
Democritus University of Thrace