Skip to content

Corneal Glue Study: effect of corneal adhesive on preventing fluid ingress after cataract surgery

Corneal Glue Study: effect of corneal adhesive on preventing fluid ingress after cataract surgery ? a randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40512708
Enrollment
20
Registered
2013-02-25
Start date
2013-02-02
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Cataracts Ear, Nose and Throat Cataract, unspecified

Interventions

Randomisation of patients: All patients will undergo routine cataract surgery. At the end of routine surgery the corneal wound will be assessed for an obvious leak. If a leak is found the patient will

Sponsors

Whipps Cross University Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Fit and well 2. Uncomplicated cataract surgery 3. Male and female patients over 45 years of age

Exclusion criteria

Exclusion criteria: 1. Any patient regarded as having clinically significant blepharitis (contraindication to use of biodendrimer glue) 2. Any patient requiring a general, subtenons or peribulbar anaesthetic 3. Any patient requiring intraoperative trypan blue for capsular visualization 4. Any patient who has an intraoperative complication including capsular rupture, zonular dehiscence, suprachoriodal haemorrhage and vitreous loss 5. Any patient who is found to have an actively leaking wound at the end of surgery 6. Patients aged 45 or younger 7. Patients having undergone previous surgery (i.e., vitrectomy, glaucoma filtration surgery) 6. Patients with pre-existing corneal disease (i.e., keratoconus, Fuch?s endothelial dystrophy) 8. Patients who lack the capacity to consent for cataract surgery (i.e., those who would need a consent form 4 or consultant consent signed for them in their best interests)

Design outcomes

Primary

MeasureTime frame
1. Corneal wounds wound be described as gaping internally, gaping externally, open or closed based on morphological characteristics. 2. A log of aqueous trypan blue concentration would be used as a marker for ingress. Measured at 1 hour, 1 day and 1 week post surgery.

Secondary

MeasureTime frame
Patient symptoms post-operatively measured at 1 hour, 1 day and 1 week post surgery.

Countries

United Kingdom

Outcome results

None listed

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