Interval Intraocular Pressure in Intravitreal Injection Study

Glaucoma Clinical Trial

— IIII  

Official title:

The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868175
• Other study ID #: IIII
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure

Intervention

Drug:
• Timolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
• Travatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
• Hypromellose
Placebo eye drop, lubricant

Locations

Country	Name	City	State
Hong Kong	HKSDS Program	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP effect of prophylactic IOP lowering eye drops over multiple time points	IOP in mmHg	From baseline to 30 minutes after injection
Secondary	IOP effect of intravitreal injection	IOP in mmHg	From baseline to 30 minutes after injection
Secondary	IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities	IOP in mmHg	From baseline to 30 minutes after injection
Secondary	Inflammation to types of anti VEGF	presence of inflammation	1 week post injection