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OpenTrials
Completed

NCT Number: NCT06555224

Role of Postoperative Lubrication in Cataract Surgery

Cataract and dry eye are two conditions occurring frequently in the elderly. Several reports suggested a deterioration of dry eye after cataract surgery, causing a significant impact on patients' postoperative satisfaction as well as quality of life. Recently, a novel index, assessing the risk of developing dry eye after cataract surgery in a non-dry eye population, was published; the so called - Ocular Surface Frailty Index (OSFI). This score utilizes 10 items including clinical ocular findings, medical history as well as environmental factors and grade the respective subject in low-risk- or high-risk group. Using the cutoff of 0.3, the rate of postoperative dry eye was 9,6% in the low-risk group and 50% in the high-risk group (p<0.001).

Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid. Previous studies found an increase in tear film stability and reduction of subjective complaints. In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing.

The current study seeks to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.

The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) works to treat prevent postoperative dry eye in adults undergoing cataract surgery. The main questions it aims to answer are:

- to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.

Participants will:

Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication (NSAID topical 2x daily for 4 weeks) after surgery Visit the clinic after 7 days, 1 month and 3 months after cataract surgery

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age older than 18 years
  • Cataract surgery scheduled in one or both eyes
  • Scheduled for monofocal or monofocal-toric IOL implantation
  • OSDI lower than 14
  • OSFI higher or equal to 0.3 - Group 1 and Group 2
  • OSFI lower than 0.3 - Group 3

Exclusion criteria

  • Presence of dry eye symptoms preoperatively
  • Occurrence of complications during surgery
  • Usage of systemic antibiotic therapy
  • Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
  • Ocular surgery within prior 3 months
  • Ocular injury within prior 3 months
  • Ocular herpes of eye or eyelid within prior 3 months
  • Active ocular infection
  • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
  • Eyelid abnormalities that affect lid function
  • Ocular surface abnormality that may compromise corneal integrity
  • Pregnancy

Treatment and study plan

Systane Hydration MDPF eye drops

Device

Systane Hydration MDPF eye drops 4x daily for 3 months additional to routine medication after cataract surgery

Primary outcomes

  1. Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit

    Time frame: 3 months visit

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

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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