Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868175
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-20
Brief Title:
Interval Intraocular Pressure in Intravitreal Injection Study
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IIII
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None