Table 3 Modifications made following round 1 and round 2 CD interviews

Round 1

Item assessing seeing objects up close while engaging in hobbies

n = 17/17 (100%)

Ten patients (n = 10/17, 58.8%) discussed the examples provided of hobbies requiring near vision (e.g. playing card games, sewing, seeing photographs). Of these patients, the majority (n = 7/10, 70.0%) felt that the examples varied in difficulty. Specifically, all seven patients felt that sewing was more challenging than the other examples provided

“Well sewing is much more difficult. That would be extremely difficult. Um, card games would be pretty easy and photographs would be okay. Um, yeah. Those, those are fine.” (M65-MOD-R1-US6)

Examples were revised from ‘playing card games, sewing, seeing photographs’ to ‘playing board games, completing puzzles, arts and crafts activities’

Item assessing seeing things in dim light

n = 17/17 (100%)

Ten patients (n = 10/17, 58.8%) suggested additional instances where they had experienced difficulties seeing objects in dim or poor light. Examples included: reading a book at night (n = 5/10, 50.0%), seeing objects when in a bar or restaurant (n = 2/10, 20.0%), entering a combination on a safe (n = 1/10, 10.0%; F54-MILD-R1-US5), reading instruction manuals (n = 1/10; 10.0%; M61-MOD-R1-DE2) and looking at maps in poor lighting (n = 1/10, 10.0%; M53-MILD-R1-DE3)

“Well, for me … because as I was telling you, I thought about restaurants, bars, etc., whereas it can simply relate to a small bedside lamp when you read, and you can have difficulty in this case.” (F41-MILD-R1-FR4)

Example of ‘reading a book by lamp light’ was added

Item assessing difficulty with near vision in bright light

n = 7/17 (41.2%)

Ten participants focused on ‘glare’ rather than their vision in bright light

“That needs to be changed …it says seeing objects close to you in bright light such as seeing dashboard in a car. The dashboard doesn’t have lighting that bright …What you see is the light that reflects out there that comes.” (F55-MILD-R1-US3)

Examples revised from ‘seeing the dashboard in a car’ to ‘reading outdoors in daylight, seeing details on objects in a brightly lit store’

Item assessing difficulty seeing contrasts in near vision

n = 15/17 (88.2%)

Two participants did not understand the description of contrast and instead answered the question based on reading small text only

“How much difficulty have you had reading small text which is in a similar color to the background, such as website and leaflets? Never thought about that. Small text, it's getting a moderate difficulty.” (F54-MILD-R1-US5)

No modifications made

Item assessing difficulty maintaining focus in near vision

n = 9/17 (52.9%)

Seven participants described mental focus rather than visual focus

“…yes, but it’s much more difficult to… I’d say, to explain. It’s essentially impressions. So, well … tell you that I have precisely difficulties remaining focused… I can’t… I can’t assure you of it.” (M51-MOD-R1-FR1)

Item 12 was reworded

New item added

N/A

Thirteen patients (n = 13/32, 40.6%) reported having difficulty completing precision tasks that required them to see small details in their near vision during the CE interviews and round 1 of the combined CE/CD interviews. Of these patients, nine (n = 9/13, 69.2%) described this experience spontaneously during their interview. The most common type of precision activities reported by patients was sewing (n = 10)

Item to assess seeing fine detail was developed

New item added

N/A

Nine patients (n = 9/32, 28.1%) during the CE interviews and round 1 of the combined CE/CD interviews described their eyes taking longer time to adjust to see things when the distance of vision changes, as a result of presbyopia. Eight of these nine patients (88.9%) reported this concept spontaneously

Item to assess difficulty adjusting from far vision to close vision was developed

Near vision correction independence item

n = 17/17 (100%)

The majority of participants (n = 14/17, 82.4%) were able to select an appropriate response to this item without difficulty

Three patients (n = 3/17, 17.6%) provided more detailed feedback on the response options. One patient (n = 1/3, 5.9%; F58-MOD-R1-FR1) indicated that she would ideally want to respond ‘3/4 of the time’, which is not captured in the current response options. The other two patients (n = 2/3, 66.7%) felt the response options were too broad. FDA also provided feedback on the response options

“That's a bit funny now, because of all the activities. In the last 7 days. Less than half. That's very wide. Above all: At night you usually don't wear glasses. Perhaps it would be better to wear them during the day. That's my opinion.” (M53-MILD-R1-DE3)

Updated to include ‘magnifying glass’ as a method of vision correction. An alternative set of response options (‘Never’ to ‘Always’) was developed for the NVCI to be debriefed alongside the original response options (‘None of the time’ to ‘All of the time’) in round 2

Near vision satisfaction item

n = 16/17 (94.1%)

Minor wording changes were implemented ahead of the next round of interviews to ensure that the patients were considering their vision without using any vision correction aids (e.g. glasses, contact lenses or a magnifying glass)

Updated to include ‘magnifying glass’ as a method of vision correction

Near vision correction preference item

n = 17/17 (100%)

The project team decided that this item would be more useful if the response options described the actual correction methods that would be expected to be used

The response options in the NVCP were updated to describe actual correction methods, rather than the options of ‘study treatment’ and ‘treatment before study’

Patient global impression of severity of presbyopia item

n = 17/17 (100%)

The PGIS-Presbyopia item was updated to align with FDA-recommended example items (outlined in Patient Focused Drug Development Guidance (Guidance 3)) [30]

The PGIS-Presbyopia response options were updated to remove ‘Very mild’ and include ‘Very severe’

Patient global impression of change in presbyopia item

n = 16/17 (94.1%)

The PGIC-Presbyopia item was updated to align with FDA-recommended example items (outlined in Patient Focused Drug Development Guidance (Guidance 3)) [30]

The PGIC-Presbyopia response options were updated to reduce the number of options from seven to five: ‘Much worse’, ‘A little worse’, ‘No change’, ‘A little better’, ‘Much better’

Round 2

Item assessing difficulty in reading small printed text on paper

n = 16/18 (88.9%)

Misinterpreted by two participants to be asking about reading from a tablet device (n = 1) or a smartphone (n = 1)

“Because sometimes you have the tablet and want to read something and wonder if you see this correctly.” (M47-MILD-R2-DE2)

Item formatting updated to bolden the words ‘on paper’

Item assessing difficulty reading small digital text on a tablet device

n = 15/18 (83.3%)

Misinterpreted by two participants to be asking about reading from a laptop (n = 1) or a smartphone (n = 1). Two participants (n = 2/18, 11.1%) overlooked the instruction ‘without increasing font size’

“…but to me, the tablet, it’s my smartphone” (M56-MILD-R2-FR6)

Item formatting updated to bolden the words ‘without increasing font size’

Item assessing difficulty seeing the keypad on a smartphone or tablet screen

n = 12/18 (66.7%)

Six participants incorrectly interpreted ‘keypad’ as referring to computer keyboards or buttons on their mobile phone

“A keypad is something where you press something down, not a touchscreen.” (F40-MILD-R2-DE1)

Item wording was changed from ‘device’ to ‘screen’ to improve comprehension

Item assessing seeing things in dim light

n = 17/18 (94.4%)

Six participants (n = 6/18, 33.3%) suggested additional examples of activities where they had experienced difficulties seeing objects in dim or poor light. This included: reading from a TV screen (n = 3/6, 50.0%), watching movies (n = 1/6, 16.7%; F42-MOD-R2-US3), reading in bed at night (n = 1/6, 16.7%; F60-MOD-R2-US4) and reading outside at dusk (n = 1/6, 16.7%; F60-MOD-R2-US4)

“Um, even at night if you’re just trying to read a book in bed and not disturbing the other person, you have your book light on, it’s difficult.” (F60-MOD-R2-US4)

The example provided was revised to better represent the lighting condition specified

Item assessing ability for the eye to adjust between different distances

n = 13/18 (72.2%)

Five participants either had a general misunderstanding of the concept (n = 3) or focussed on a change in lighting conditions due to the example provided (n = 2)

INTERVIEWER: “How would you ask this question in your own words?” PATIENT: “How difficult is it for you to see things in different lighting?” (F48-MOD-R2-US1)

Item revised from referring to ‘looking out the window’ to ‘look across the room’ to avoid the risk of responses being influenced by the different lighting and weather conditions which may impact vision outdoors