Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

NCT ID: NCT02558218

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-05-31

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).

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Systane Ultra

Intervention Type: DRUG

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

Control group

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

Group Type: ACTIVE_COMPARATOR

tobradex quid (Standard)

Intervention Type: DRUG

Standard medication (tobradex quid for 20 days)

Interventions

Systane Ultra

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

Intervention Type: DRUG

tobradex quid (Standard)

Standard medication (tobradex quid for 20 days)

Intervention Type: DRUG

Other Intervention Names

Administration of Systane Ultra (Alcon); Standard Medication

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Georgios Labiris

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Labiris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Eye Institute Of thrace

Alexandroupoli, Evros, Greece

Countries

Greece

References

Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.

Reference Type: DERIVED

PMID: 28497070 (View on PubMed)

Other Identifiers

FBCat

Identifier Type: -

Identifier Source: org_study_id