None listed
Conditions
Brief summary
This study is been carried out to investigate if transplanting minor salivary glands into the eyelid will provide adequate symptomatic relief from severe dry eye disease. Studies have shown that the composition of salivary secretions is fairly similar to that of natural tears, thus making it a promising potential source of tears for patients with severe dry eye disease. If the procedure is successful, it will restore a natural tear film to the eye, and help prevent the symptoms of dry eye including pain, visual disturbance and light sensitivity. If successful it will also reduce or even remove the need for artificial tear drops.
Interventions
The composition of saliva is very similar to tears. Minor salivary gland harvested from the lips and implanted into the eyelid to help produce saliva which alleviate dry eye disease.
Grafts of the labial/buccal mucosa with attached minor salivary glands will be taken. A full thickness mucosal graft together with attached salivary glands will be harvested and placed in povidone. As glandular density per surface area is highest in the lower lip, labial mucosa from the lower lip should be taken b
The composition of saliva is very similar to tears. Minor salivary gland harvested from the lips and implanted into the eyelid to help produce saliva which alleviate dry eye disease. Grafts of the labial/buccal mucosa with attached minor salivary glands will be taken. A full thickness mucosal graft together with attached salivary glands will be harvested and placed in povidone. As glandular density per surface area is highest in the lower lip, labial mucosa from the lower lip should be taken but the buccal and upper lip can also be used as donor site if required. The recipient bed will be prepared by everting the lower eyelid and an injection of saline or anaesthetic will be administered to allow for separation of the conjunctiva from the underlying Muller’s muscle. An incision will be made in the lower conjunctival fornix before the graft is cut to shape and sutured into the lower conjunctival fornix. A bandage contact lens will be applied or, if this is to be avoided, grafts will be held in place with two horizontal running prolene 4-0 sutures along their upper and lower horizontal border. Both sutures will then be passed transpalpebrally out to the skin and externalised ends tied together. Antibiotic eyedrops and pressure bandages will be used for up to 1 week post-operative. The surgery will only be performed once and will last about 120 minutes Post-operative treatment will include application of topical antibiotics and lubricants 4-8 times daily for 2 weeks, after which sutures can be removed (if prolene used).
Sponsors
Dinesh Selva
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All patients with severe DED defined by OSDI score and stage 4 dry eye severity grading scheme Persistant severe pain and symptoms Marked conjunctival staining Severe corneal erosions Flourescein tear break up time immediate (TBUT) Schirmer score <2 Inclusion for healthy control group: Clinically no evidence of dry eye disease Able to attend the follow-up appointments
Exclusion criteria
Age <18 years old Pregnancy Inability to provide consent Previous gland graft Existing ocular disease Subjects using topical or systemic medications for allergies Contact lens wearers Smokers Exclusion criteria for control group: Pregnancy Inability to provide consent Existing ocular disease Subjects using topical or systemic medications for allergies Contact lens wearers Smokers
Outcome results
None listed