Interval Intraocular Pressure in Intravitreal Injection Study (IIII)

The University of Hong Kong (HKU)

Status: Completed

Conditions: Glaucoma; Intraocular Pressure

Treatments: Drug: Hypromellose; Drug: Timolol; Drug: Travatan

Study type: Interventional

Funder types: Other

Identifiers

NCT04868175

IIII

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 3 patient groups

Group 1

Active Comparator group

Description:

control (hypromellose), then Timolol, then Travatan

Treatment:

Drug: Hypromellose

Drug: Travatan

Drug: Timolol

Group 2

Active Comparator group

Description:

Timolol, then Travatan, Hypromellose

Treatment:

Drug: Hypromellose

Drug: Travatan

Drug: Timolol

Group 3

Active Comparator group

Description:

Travatan, then Hypromellose, Timolol

Treatment:

Drug: Hypromellose

Drug: Travatan

Drug: Timolol