Interval Intraocular Pressure in Intravitreal Injection Study

Not Applicable

Completed

• Conditions: Glaucoma; Intraocular Pressure
• Interventions: Drug: Timolol; Drug: Travatan; Drug: Hypromellose

• Registration Number: NCT04868175
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-03-01
• Status Verified: 2021-04
• Study Completion: 2021-04-01
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Travatan	control (hypromellose), then Timolol, then Travatan
Group 2	Travatan	Timolol, then Travatan, Hypromellose
Group 3	Travatan	Travatan, then Hypromellose, Timolol
Group 2	Timolol	Timolol, then Travatan, Hypromellose
Group 1	Timolol	control (hypromellose), then Timolol, then Travatan
Group 1	Hypromellose	control (hypromellose), then Timolol, then Travatan
Group 2	Hypromellose	Timolol, then Travatan, Hypromellose
Group 3	Timolol	Travatan, then Hypromellose, Timolol
Group 3	Hypromellose	Travatan, then Hypromellose, Timolol

Primary Outcome Measures

Name	Time	Method
IOP effect of prophylactic IOP lowering eye drops over multiple time points	From baseline to 30 minutes after injection	IOP in mmHg

Secondary Outcome Measures

Name	Time	Method
IOP effect of intravitreal injection	From baseline to 30 minutes after injection	IOP in mmHg
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities	From baseline to 30 minutes after injection	IOP in mmHg
Inflammation to types of anti VEGF	1 week post injection	presence of inflammation

Trial Locations

Locations (1)

HKSDS Program; 🇭🇰 Hong Kong, Hong Kong