The questionnaires
Quality-of-life research on scleral lenses relies mainly on two validated questionnaires. “Validated” means researchers tested that the questionnaire measures what it claims, gives consistent answers, and tells apart people with milder and more severe problems.
NEI VFQ-25: how vision affects daily life
The 25-item National Eye Institute Visual Function Questionnaire asks how your vision affects everyday life. It was shortened from a 51-item version and tested in 11 university ophthalmology practices and the NEI Clinical Center, in people with cataract, macular degeneration, diabetic eye disease, glaucoma, cytomegalovirus retinitis, or low vision.[1] Scores run on a 100-point scale, and higher is better.[4] Studies of scleral lenses report its subscales for things like near and distance activities, driving, social functioning, and mental health[19], as well as eye pain, role difficulties, and dependency on others.[5]
Note that it wasn’t developed specifically for corneal disease or contact lens wearers.[1] Some studies use the longer 39-item version instead.[8]
OSDI: eye surface symptoms
The Ocular Surface Disease Index is a 12-item questionnaire on dry eye symptoms and how they limit vision-related tasks. In its validation study of 109 people with dry eye and 30 without, it was reliable, matched doctors’ assessments of severity, and had three parts: vision-related function, eye symptoms, and environmental triggers.[2][3]
Scores run from 0 to 100, and lower is better. A score of 0 to 12 is considered normal, 13 to 22 mild, 23 to 32 moderate, and 33 to 100 severe.[3]
How big a change matters
A change on a questionnaire can be statistically significant without being noticeable to the patient. For the OSDI, researchers estimated the smallest change patients notice, the minimal clinically important difference: 7.0 to 9.9 points overall, 4.5 to 7.3 for mild or moderate disease, and 7.3 to 13.4 for severe disease.[3] We didn’t find a comparable published figure for the VFQ-25 in corneal disease, so we haven’t given one.
NEI VFQ-25 results
| Study | Who | Design | Change in score[5][4][7][9][10][11][12] |
|---|---|---|---|
| Stason 2010 | 101 patients, irregular corneas or surface disease (PROSE) | Prospective, 6 months | 57.0 → 77.8 |
| Baran 2012 | Corneal ectasia (PROSE), 89 eyes fitted | Records review, 6 months | +27.6 points among those still wearing |
| Baudin 2021 | Keratoconus, 41 eyes of 24 people | Prospective, 3 months | +19.5 points on average |
| DeLoss 2016 | Ocular GVHD, 407 patients in a PROSE database | Database review, 6 months | +41 points across the network; +30 at the main center |
| Papakostas 2015 | Stevens-Johnson syndrome or TEN, 86 patients (PROSE) | Retrospective, 6 months | 48 → 72 |
| Tougeron 2009 | Stevens-Johnson syndrome or TEN, 39 patients | Retrospective, 6 months | 25.1 → 67.4 |
| Lu 2025 | Severe dry eye, 15 patients (Chinese version) | Prospective, 1 month | Median 74.4 → 95 |
Sources: Stason[5], Baran[4], Baudin[7], DeLoss[9], Papakostas[10], Tougeron[11], Lu[12].
A few patterns:
- Starting point shapes the gain. People with severe Stevens-Johnson syndrome started very low (25.1 in one study) and gained the most.[11] People with milder starting scores have less room to improve.
- Different conditions improve in different ways. In the Stason study, overall gains were similar for irregular corneas and surface disease, but vision items improved more with irregular corneas, while pain, role difficulties, and dependency improved more with surface disease.[5]
- Keratoconus studies agree. Besides the French study in the table, a Belgian study of 50 people using the 39-item version found significant gains in visual functioning and social and emotional wellbeing among those still wearing lenses at six months.[8] More keratoconus detail is on the keratoconus research page.
Does it last?
The longest follow-up comes from a five-year review of 121 PROSE patients. NEI VFQ-25 scores rose by 23 points at six months, with no significant decline among those still wearing a device at five years (average 78). At five years, wearers scored higher than people who had stopped (78 vs 70).[6] That comparison can’t separate the effect of the device from the reasons people stopped.
OSDI results
All of these studies were in people with severe surface disease, and all reported a large drop in symptom scores.
| Study | Who | OSDI before → after[13][14][15][16][17][11][12] |
|---|---|---|
| Takahide 2007 | Ocular GVHD, 9 patients | Median 81 → 21 within 2 weeks |
| Magro 2017 | Ocular GVHD, 60 patients | Average 86 → 30 at 2 months |
| Theophanous 2015 | Ocular GVHD, 29 patients assessed at follow-up | Average 72.6 → 21.1 |
| Keye 2024 | Ocular GVHD, 31 patients | Median 73 → 27 |
| Tougeron 2009 | Stevens-Johnson syndrome or TEN, 39 patients | Average 76.9 → 37.1 at 6 months |
| Heur 2014 | Stevens-Johnson syndrome, 16 patients | Average 70.4 → 37.4 |
| Lu 2025 | Severe dry eye, 15 patients | Average 53.9 → median 10.4 at 1 month |
Sources: Takahide[13], Magro[15], Theophanous[14], Keye[16], Tougeron[11], Heur[17], Lu[12].
Every baseline score here falls in the severe range (33 or more), and the drops of roughly 33 to 60 points are several times the minimal clinically important difference for severe disease.[3] Many follow-up scores remain in the moderate or severe range, though: scleral lenses reduced symptoms but did not make them disappear for many people.
The OSDI is also used outside dry eye. In a PROSE series of 90 eyes with irregular corneas, people with astigmatism after a corneal transplant had the largest improvement, 79%.[18]
Children
In a study of 25 eyes of children fitted with scleral lenses for keratoconus, surface disease, or corneal injury repair, a pediatric questionnaire (PedEye-Q) showed significantly better quality of life for the child after one month, and parents’ own quality of life improved too.[22]
Results that cut the other way
Not every study points in the same direction, and these are worth knowing:
- Against corneal rigid lenses, no difference. In a randomized crossover trial, 30 people who already wore corneal rigid lenses successfully tried both types. Scleral lenses were rated more comfortable, but NEI VFQ-25 scores were not significantly different.[20] The large gains in other studies come from people whose previous correction wasn’t working.
- Surgery scored higher in one cross-sectional study. Among 490 people with keratoconus in one eye, those who’d had surgery (ring segments or transplants) had higher NEI VFQ-25 scores than those treated without surgery (cross-linking, rigid lenses, or scleral lenses).[21] This was a one-time snapshot of different people, not a before-and-after comparison, and people are offered different treatments for different reasons, so it can’t show which treatment works better.
For the broader evidence on vision and dropout, see scleral lens outcomes research.
Common questions
Do scleral lenses improve quality of life?
In the studies we found, people fitted with scleral lenses reported better daily visual functioning and fewer symptoms, often by large margins. In a prospective study of 101 patients with irregular corneas or surface disease, the average NEI VFQ-25 score rose from 57.0 to 77.8 out of 100 after six months. Most studies had no comparison group, so they show improvement after fitting, not how scleral lenses compare with other options.
What is the NEI VFQ-25?
A 25-item questionnaire from the US National Eye Institute that asks how your vision affects activities such as reading, driving, and social life. It was developed and validated in people with conditions like cataract, macular degeneration, diabetic eye disease, glaucoma, and low vision. Scores run up to 100, and higher means better visual functioning.
What is the OSDI?
The Ocular Surface Disease Index is a 12-item questionnaire on dry eye symptoms and how they limit vision-related tasks. Scores run from 0 to 100. A score of 0 to 12 is considered normal and 33 or more severe.
Do the benefits last?
One five-year study suggests so for people who keep wearing them. Among PROSE wearers, NEI VFQ-25 scores rose 23 points at six months, with no significant decline by five years. People still wearing their devices at five years scored higher than those who had stopped.
Are scleral lenses better for quality of life than corneal rigid lenses?
Not necessarily. In a randomized crossover trial of 30 people who already wore corneal rigid lenses successfully, NEI VFQ-25 scores were not significantly different between the two lens types, though scleral lenses were rated more comfortable.