Specialty: Ophthalmology, Primary sub-specialty: Other
Conditions
Interventions
Randomisation is computer generated sequential binary randomisation in blocks of 10.
Punctal plugs treatment arm:
Perforated punctal plugs, coated with a thin layer of polyvinylpyrrolidone (PVP) sil
with the lower eyelid on lateral stretch, the punctum and proximal canaliculus is dilated with a Nettleship dilator. The PPP is inserted soon after dilatation. The inserter is held between the thumb a
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years (men and women) 2. Epiphora as a result of acquired punctal stenosis of lower lids 3. Full patency on lacrimal syringing 4. Willing to undergo a procedural intervention 5. Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. History of congenital punctal stenosis 2. History of punctal stenosis associated with chemotherapy 3. Completely stenosed or occluded punctum 4. Abnormality on lacrimal syringing 5. Moderate or severe lower eyelid laxity or eyelid malposition 6. Use of eye drops, other than lubricants, within the past 3 months or planned in the study eye during the course of the trial 7. Eyelid or ocular surgery within the past 3 months or planned surgery in the study eye, during the course of the trial 8. Planned chemotherapy during the course of the trial 9. Planned nasal or sinus surgery during the course of the trial 10. Any other condition or situation that, in the opinion of the investigator, may prevent the participant complying with the study or follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated number of times eye has watered in the past week, as assessed by questions 2 and 3 in the Imperial Watery Eye Quality of Life Questionnaire at baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of watering on quality of life, assessed on an 11-point numerical rating scale as part of the watery eye quality of life questionnaire (Appendix 6), at 12 months post procedure; in the case of PPPs this will be 12 months post plug removal. 2. Slit lamp examination of punctum. A punctum size of Grade 3-5, as defined on the visual grading system by Kashkouli et al, (Appendix 4) will be considered successful 3. Slit lamp examination of tear meniscus. A tear meniscus greater than 0.3mm will be considered raised, a secondary measure of anatomical failure. 4. OCT of lacrimal punctum. There are not sufficient normative databases in the literature to use as a reference but we will compare figures pre- and post-operatively to assess the effect of the treatments and to assess the utility of OCT as a tool for analysing puncta | — |
Countries
United Kingdom
Outcome results
None listed