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

Completed
Conditions
Cataracts
Ear, Nose and Throat
Cataract, unspecified
Registration Number
ISRCTN40512708
Lead Sponsor
Whipps Cross University Hospital (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Corneal wounds wound be described as gaping internally, gaping externally, open or closed based on morphological characteristics.<br>2. A log of aqueous trypan blue concentration would be used as a marker for ingress.<br><br>Measured at 1 hour, 1 day and 1 week post surgery.
Secondary Outcome Measures
NameTimeMethod
Patient symptoms post-operatively measured at 1 hour, 1 day and 1 week post surgery.
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