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Role of Postoperative Lubrication in Cataract Surgery

Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06555224
Enrollment
100
Registered
2024-08-15
Start date
2021-06-22
Completion date
2023-12-18
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief summary

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

Interventions

DEVICESystane Hydration MDPF eye drops

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

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator will be masked to study group allocation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit3 months visit

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026