Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedSeptember 23, 2015
September 1, 2015
4 months
September 15, 2015
September 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Foreign body sensation
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
1 month postoperatively
Secondary Outcomes (2)
Ocular Redness
7 days postoperatively
Corneal Sensitivity
1 month postoperatively
Study Arms (2)
Systane ultra group
ACTIVE COMPARATORParticipants 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.
Control group
ACTIVE COMPARATORParticipants in this group were administered the standard postoperative medication \[tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.\]
Interventions
Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
Standard medication (tobradex quid for 20 days)
Eligibility Criteria
You may qualify if:
- \. Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale
You may not qualify if:
- Endothelial cell count less than 1900,
- Glaucoma,
- IOP-lowering medications,
- Former incisional surgery,
- Former diagnosis of corneal disease,
- Diabetes or autoimmune diseases
- Former diagnosis of dry eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Institute Of thrace
Alexandroupoli, Evros, 68100, Greece
Related Publications (1)
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.
PMID: 28497070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Labiris, MD, PhD
Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 23, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09