Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02558218

Enrollment

Registered

2015-09-23

Start date

2015-01-31

Completion date

2015-05-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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).

Interventions

DRUGSystane Ultra

Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months

DRUGtobradex quid (Standard)

Standard medication (tobradex quid for 20 days)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026