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DisCoVisc versus balanced salt solution irrigation during femto second laser-assisted cataract surgery: a prospective,single-blind single centre, randomized controlled trial

DisCoVisc versus balanced salt solution irrigation during femto second laser-assisted cataract surgery: a prospective,single-b lind single centre, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050146
Enrollment
Unknown
Registered
2021-08-18
Start date
2018-05-15
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

cataract

Interventions

experimental group:An appropriate amount of DisCoVisc was applied to the central cornea during surgery
control group:Conventional femtosecond laser cataract surgery

Sponsors

Wuhan Aier Hankou Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
52 Years to 74 Years

Inclusion criteria

Inclusion criteria: For patients with simple age-related cataract, the first eye was selected by binocular surgery. According to the diagnostic criteria of dry eyes mentioned in the consensus of clinical experts in 2013: 1. dry eyes can be diagnosed with one of the subjective symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, vision fluctuation and TBUT < 5s or tear secretion test (SchirmerI, no topical anesthesia) <= 5mm/5min; 2. dry eyes can be diagnosed with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual fluctuation and 5s < BUT <=10s or 5mm/5min < SchirmerI test (no topical anesthesia) <=lOmm/5min. The corneal fluorescein staining of the patient is negative, but there are clear dry eye related subjective symptoms that can be diagnosed as mild dry eye; the patient has moderate and severe dry eye related subjective symptoms, and the keratoconjunctival fluorescein staining is positive, but it can be changed to negative diagnosis to moderate dry eye after treatment.

Exclusion criteria

Exclusion criteria: (1) recent (6 months) use of drugs that affect tear secretion and tear film stability, such as antihistamines, antidepressants, antiepileptic drugs, contraceptive, vasoconstrictors, anticholinergic drugs, glucocorticoids, non-steroidal anti-inflammatory drugs, artificial tears, anti-glaucoma drugs, etc.; (2) patients with ocular surface diseases that may affect tear film function. Such as ectropion trichiasis, eyelid insufficiency, severe meibomian gland dysfunction and atrophy, severe dry eyes, keratopathy, pterygium, long-term wearing of corneal contact lenses, lacrimal duct diseases and so on; (3) complicated with related eye diseases and surgical history, such as uveitis, glaucoma, corneal leukoplakia, allergic conjunctivitis, blepharitis, infectious ophthalmopathy and so on; (4) Femtosecond laser assisted cataract surgery contraindications, such as small palpebral fissure, severe bulbar conjunctival relaxation, high corneal curvature, poor coordination, pupil dilation larger than 5mm and so on; (5) systemic systemic diseases, such as diabetes, Stevens-Johnson syndrome, Sjogren's syndrome, thyroid associated ophthalmopathy, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, other connective tissue diseases and so on; (6) abnormal communication and comprehension ability and sensory abnormality, such as abnormal intellectual development, abnormal hearing, inability to understand Putonghua, acoustic neuroma and so on.

Design outcomes

Primary

MeasureTime frame
Percentage of subconjunctival bleeding;Intraoperative discomfort assessment;Ocular surface disease index;Tear break-up time;Corneal flurescein staining;Schirmer I test;

Countries

China

Contacts

Public ContactRong Xu

Wuhan Aier Hankou Eye Hospital

xurong_228@163.com+86 13971510596

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026