IIII: Interval Intraocular Pressure in Intravitreal Injection Study

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT04868175
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 3
• Actual Duration (Months): 18
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Intraocular Pressure	Drug: Timolol; Drug: Travatan; Drug: Hypromellose	N/A

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

1. Day 1 follow-up visit

• IOP via iCare (sitting)

• Slitlamp examination, document inflammation or complications if any

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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.
• Masking: Double (Participant, Care Provider)
• Masking Description: Patients are not exposed to the eye drop bottle (taped) and the doctors measuring pressure and performing the intravitreal injections are not shown the eye drops given
• Primary Purpose: Prevention
• Official Title: The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 control (hypromellose), then Timolol, then Travatan	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant
Active Comparator: Group 2 Timolol, then Travatan, Hypromellose	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant
Active Comparator: Group 3 Travatan, then Hypromellose, Timolol	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant

Outcome Measures

Primary Outcome Measures

1. 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

1. IOP effect of intravitreal injection [From baseline to 30 minutes after injection]

   IOP in mmHg

2. 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

3. Inflammation to types of anti VEGF [1 week post injection]

   presence of inflammation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HKSDS Program	Hong Kong		Hong Kong	000000

Sponsors and Collaborators

• The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04868175
• Other Study ID Numbers: IIII
• First Posted: Apr 30, 2021
• Last Update Posted: Apr 30, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma; Timolol; Travoprost

Study Results

No Results Posted as of Apr 30, 2021