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Completed

NCT Number: NCT02558218

Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Institute Of thrace

Alexandroupoli, Evros, 68100, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Systane Ultra

Drug

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

Other names: Administration of Systane Ultra (Alcon)

tobradex quid (Standard)

Drug

Standard medication (tobradex quid for 20 days)

Other names: Standard Medication

Primary outcomes

  1. Foreign body sensation

    Time frame: 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 outcomes

  1. Ocular Redness

    Time frame: 7 days postoperatively

    Ocular redness will be assessed by means of a validated photographic chart

  2. Corneal Sensitivity

    Time frame: 1 month postoperatively

    Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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