Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-09-15

Brief Summary

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Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

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Detailed Description

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Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group \[who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks\], and control group \[who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks\].

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study group

Sodium Hyaluronate 0.1% drops

Group Type ACTIVE_COMPARATOR

Sodium Hyaluronate 0.2% drops

Intervention Type DRUG

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Control group

Sodium Hyaluronate 0.2% drops

Group Type ACTIVE_COMPARATOR

Sodium Hyaluronate 0.1% drops

Intervention Type DRUG

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

Interventions

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Sodium Hyaluronate 0.1% drops

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

Intervention Type DRUG

Sodium Hyaluronate 0.2% drops

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Intervention Type DRUG

Other Intervention Names

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Sodium Hyaluronate 0.1% drops (artificial tear medication) Sodium Hyaluronate 0.2% drops (artificial tear medication)

Eligibility Criteria

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Inclusion Criteria

* 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. Diagnosis or evidence of dry-eye-disease (DED)
2. IOP-lowering medications
3. Former incisional surgery
4. Former diagnosis of corneal disease
5. Diabetes
6. Autoimmune diseases
7. Mental diseases

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No