Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: tobradex quid (Standard); Drug: Systane Ultra

• Registration Number: NCT02558218
• Lead Sponsor: Democritus University of Thrace

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Study First Posted: 2015-09-23
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	tobradex quid (Standard)	Participants in this group were administered the standard postoperative medication \[tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.\]
Systane ultra group	Systane Ultra	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.

Primary Outcome Measures

Name	Time	Method
Foreign body sensation	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 Outcome Measures

Name	Time	Method
Corneal Sensitivity	1 month postoperatively	Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day
Ocular Redness	7 days postoperatively	Ocular redness will be assessed by means of a validated photographic chart

Trial Locations

Locations (1)

Eye Institute Of thrace; 🇬🇷 Alexandroupolis, Evros, Greece