Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery
Impact of 0.1% Sodium Hyaluronate and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Cataract Extraction Surgery, a Comparative Study
1 other identifier
interventional
180
1 country
1
Brief Summary
Primary objective of the study is the assessment of the patients' discomfort 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 P75+ for not_applicable
Started Sep 2017
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
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedOctober 15, 2018
October 1, 2018
1 year
October 11, 2018
October 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Surface Discomfort Index
A subjective parameter that quantifies corneal discomfort
6 weeks
Secondary Outcomes (2)
Break up time
6 weeks
Central Corneal Sensitivity
6 weeks
Study Arms (2)
Study group
ACTIVE COMPARATORSodium Hyaluronate 0.1% drops
Control group
ACTIVE COMPARATORSodium Hyaluronate 0.2% drops
Interventions
Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
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:
- Diagnosis or evidence of dry-eye-disease (DED)
- IOP-lowering medications
- Former incisional surgery
- Former diagnosis of corneal disease
- Diabetes
- Autoimmune diseases
- Mental diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Democritus University of Thracelead
- Naval Hospital, Athenscollaborator
- George Papanicolaou Hospitalcollaborator
- Athinaiki General Cliniccollaborator
Study Sites (1)
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
Related Publications (1)
Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019.
PMID: 30805405DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Georgios Labiris, MD, PhD
University Hospital of Alexandroupolis, Democritus University of Thrace
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
- Associate Professor of Ophthalmology
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 15, 2018
Study Start
September 15, 2017
Primary Completion
September 15, 2018
Study Completion
September 15, 2018
Last Updated
October 15, 2018
Record last verified: 2018-10