Clinical trial NCT04868175: Interval Intraocular Pressure in Intravitreal Injection Study
Official title: The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

* AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
* Age \>50
* Chinese patients with ability to read Chinese ICF

Exclusion Criteria:

1. Known glaucoma
2. Corneal disease e.g. corneal scarring or opacity preventing fundal view
3. On steroid or anti glaucoma eye drops
4. Prior vitrectomy or glaucoma surgery
5. Recent intraocular surgery i.e. cataracts surgery
6. Pseudophakic with anterior chamber IOL
7. History of ocular inflammatory disease e.g. uveitis
8. Previous laser iridotomy
9. Recent intravitreal injection of steroid
10. Inability for regular follow-up

Primary outcomes:
measure: IOP effect of prophylactic IOP lowering eye drops over multiple time points
timeFrame: From baseline to 30 minutes after injection
Secondary outcomes:
measure: IOP effect of intravitreal injection
timeFrame: From baseline to 30 minutes after injection
measure: IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities
timeFrame: From baseline to 30 minutes after injection
measure: Inflammation to types of anti VEGF
timeFrame: 1 week post injection
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: HKSDS Program
Study officials:
References: