NCT06555224

Role of Postoperative Lubrication in Cataract Surgery

Completed Phase 4 Last updated 15 August 2024

What this trial tests

Phase 4 trial testing Systane Hydration MDPF eye drops in Dry Eye in 100 participants. Completed in 18 December 2023.

Timeline

22 June 2021

Primary endpoint
18 December 2023

18 December 2023

Quick facts

Lead sponsor	Vienna Institute for Research in Ocular Surgery
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	100
Start date	22 June 2021
Primary completion	18 December 2023
Estimated completion	18 December 2023
Sites	1 location across Austria

Drugs / interventions tested

• Systane Hydration MDPF eye drops

Conditions studied

• Dry Eye — all drugs for Dry Eye →

Sponsor

Vienna Institute for Research in Ocular Surgery

Who can join

18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Role of postoperative lubrication in preventing dry eye after cataract surgery in high- and low-risk patients stratified by ocular surface frailty index.
   Palkovits S, Schlatter A, Ruiss M, Fisus A, et al · · 2025 · cited 3× · PMID 40138387 · DOI 10.1371/journal.pone.0312712