Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Democritus University of Thrace

Status: Completed

Conditions: Cataract

Treatments: Drug: Systane Ultra; Drug: tobradex quid (Standard)

Study type: Interventional

Funder types: Other

Identifiers

NCT02558218

FBCat

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Systane ultra group

Active Comparator group

Description:

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.

Treatment:

Drug: Systane Ultra

Control group

Active Comparator group

Description:

Participants in this group were administered the standard postoperative medication \[tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.\]

Treatment:

Drug: tobradex quid (Standard)