Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04868175 |
Other study ID # |
IIII |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2019 |
Est. completion date |
April 1, 2021 |
Study information
Verified date |
April 2021 |
Source |
The University of Hong Kong |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a prospective study of IOP in Intravitreal injections to evaluate:
1. IOP effect of intravitreal injection
2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose)
over multiple time periods
3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co
morbidities
Description:
Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment:
Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.
Randomization:
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan,
Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three
groups of treatments. During the first injection visit, patients will be randomized (by
envelope method upon recruitment) to start with one of the three groups by envelope method.
Treatment given to each group according to randomization in the first visit, then rotated to
second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
Study visits:
1. Injection visit
- Record the anti-VFGF injection to be given
- Macula disease involved
- Record no. of previous injections
- Prophylactic eye drops will be given according to treatment group 1 hour prior
injection
- IOP immediately before injection (without speculum while sitting on table)
- IOP immediately after injection (without speculum while sitting on table)
- IOP 30 minutes after injection via iCare
- Slitlamp examination, document inflammation or complications if any
2. Day 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any
3. Week 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any Visit a, b and
c will be repeated for 2nd and 3rd injections.