Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus

NCT06921967 | Recruiting

• 1 other identifier: 2500206
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the ocular health and visual quality of corneal rigid gas permeable lenses (CRGPL) and scleral rigid gas permeable lenses (SRGPL) for patients with keratoconus in a crossover clinical trial. The study will analyze subjective and objective outcomes, including best corrected visual acuity, contrast sensitivity, higher-order aberrations and subjective perception of visual function and comfort. It will also investigate the impact of both lens types on the health of the ocular surface, including evaluation of corneal, conjunctival, and scleral tissues, and tear film. Only one randomized controlled trial has compared the effect of CRGPL and SRGPL wear for patients with an ectatic corneal disorder. With the increasing popularity of SRGPL, examining the differences in efficacy, safety, and patient-reported outcomes between the two types of lenses is increasingly relevant.

Conditions

Keratoconus; Irregular Astigmatism

Keywords

Contact Lenses; Scleral Lenses; Corneal Lenses; Rigid gas permeable lenses; Rigid lenses; GP lenses; RGP lenses; Visual Acuity; Contrast Sensitivity; Higher Order Aberrations; Dry Eye Disease; Irregular Astimatism; Keratoconus

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Comparison of Best Corrected Visual Acuity, with the two interventions, at the end of 6 weeks of lens wear. Measured with ETDRS charts, converted to logMAR units.

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

Secondary Outcomes (9)

• Contrast Sensitivity

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

• Higher Order Aberrations (HOA)

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

• Tear break-up time (TBUT)

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

• Anterior ocular health markers

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

• Corneal Epithelial Thickness

  6 weeks with each intervention. 13 weeks total, incl. 1 week washout.

Study Arms (2)

Corneal Rigid Gas Permeable Contact Lens

ACTIVE COMPARATOR

Small diameter RGP lens (TD \< HVID).

Device: Rose K2

Scleral Rigid Gas Permeable Contact Lens

ACTIVE COMPARATOR

Large diameter RGP lens (TD\>HVID).

Device: Onefit MED

Interventions

Rose K2 DEVICE

Corneal RGP lens with flexible parameters.

Corneal Rigid Gas Permeable Contact Lens

Onefit MED DEVICE

Scleral RGP lens with flexible parameters.

Scleral Rigid Gas Permeable Contact Lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Keratoconus, best spectacle corrected visual acuity \>0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40

You may not qualify if:

• K-max \>60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Related Publications (18)

• Morgan P, Woods C, Tranoudis I, Efron N, Jones L, Faccia P, et al. International Contact Lens Prescribing in 2023. CONTACT LENS SPECTRUM. 2024;39:20-2,4,6-8

  BACKGROUND

• Morgan P, Woods C, Tranoudis I, Helland M, N E, M T, et al. International Contact Lens Prescribing in 2013. Contact Lens Spectrum. 2014;29:30-5

  BACKGROUND

• Mandathara PS, Kalaiselvan P, Rathi VM, Murthy SI, Taneja M, Sangwan VS. Contact lens fitting after corneal collagen cross-linking. Oman J Ophthalmol. 2019 Oct 11;12(3):177-180. doi: 10.4103/ojo.OJO_43_2018. eCollection 2019 Sep-Dec.

  PMID: 31902993 BACKGROUND

• Nielsen K, Hjortdal J, Aagaard Nohr E, Ehlers N. Incidence and prevalence of keratoconus in Denmark. Acta Ophthalmol Scand. 2007 Dec;85(8):890-2. doi: 10.1111/j.1600-0420.2007.00981.x. Epub 2007 Jul 23.

  PMID: 17645421 BACKGROUND

• Bak-Nielsen S, Ramlau-Hansen CH, Ivarsen A, Plana-Ripoll O, Hjortdal J. Incidence and prevalence of keratoconus in Denmark - an update. Acta Ophthalmol. 2019 Dec;97(8):752-755. doi: 10.1111/aos.14082. Epub 2019 Apr 9.

  PMID: 30964230 BACKGROUND

• Ozcura F, Aydin S, Helvaci MR. Ocular surface disease index for the diagnosis of dry eye syndrome. Ocul Immunol Inflamm. 2007 Sep-Oct;15(5):389-93. doi: 10.1080/09273940701486803.

  PMID: 17972223 BACKGROUND

• Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.

  PMID: 11220037 BACKGROUND

• Sorensen MS, Andersen S, Henningsen GO, Larsen CT, Sorensen TL. Danish version of Visual Function Questionnaire-25 and its use in age-related macular degeneration. Dan Med Bull. 2011 Jun;58(6):A4290.

  PMID: 21651879 BACKGROUND

• Barnett M, Courey C, Fadel D, Lee K, Michaud L, Montani G, van der Worp E, Vincent SJ, Walker M, Bilkhu P, Morgan PB. CLEAR - Scleral lenses. Cont Lens Anterior Eye. 2021 Apr;44(2):270-288. doi: 10.1016/j.clae.2021.02.001. Epub 2021 Mar 25.

  PMID: 33775380 BACKGROUND

• Hwang K, Kim JH. The Risk of Blepharoptosis in Contact Lens Wearers. J Craniofac Surg. 2015 Jul;26(5):e373-4. doi: 10.1097/SCS.0000000000001876.

  PMID: 26102541 BACKGROUND

• Efron N. Contact Lens Practice. 4th ed. New Dehli: Elsevier; 2023

  BACKGROUND

• Rosenfield M, Logan N. Optometry : science, techniques and clinical management. 2nd ed. Edinburgh: Butterworth Heinemann Elsevier; 2009

  BACKGROUND

• Levit A, Benwell M, Evans BJW. Randomised controlled trial of corneal vs. scleral rigid gas permeable contact lenses for keratoconus and other ectatic corneal disorders. Cont Lens Anterior Eye. 2020 Dec;43(6):543-552. doi: 10.1016/j.clae.2019.12.007. Epub 2020 Jan 8.

  PMID: 31924530 BACKGROUND

• Romero-Jimenez M, Santodomingo-Rubido J, Gonzalez-Meijome JM. An assessment of the optimal lens fit rate in keratoconus subjects using three-point-touch and apical touch fitting approaches with the rose K2 lens. Eye Contact Lens. 2013 Jul;39(4):269-72. doi: 10.1097/ICL.0b013e318295b4f4.

  PMID: 23771007 BACKGROUND

• Michaud L, Lipson M, Kramer E, Walker M. The official guide to scleral lens terminology. Cont Lens Anterior Eye. 2020 Dec;43(6):529-534. doi: 10.1016/j.clae.2019.09.006. Epub 2019 Sep 25.

  PMID: 31561849 BACKGROUND

• Ling JJ, Mian SI, Stein JD, Rahman M, Poliskey J, Woodward MA. Impact of Scleral Contact Lens Use on the Rate of Corneal Transplantation for Keratoconus. Cornea. 2021 Jan;40(1):39-42. doi: 10.1097/ICO.0000000000002388.

  PMID: 32452985 BACKGROUND

• Koppen C, Kreps EO, Anthonissen L, Van Hoey M, Dhubhghaill SN, Vermeulen L. Scleral Lenses Reduce the Need for Corneal Transplants in Severe Keratoconus. Am J Ophthalmol. 2018 Jan;185:43-47. doi: 10.1016/j.ajo.2017.10.022. Epub 2017 Nov 16.

  PMID: 29103959 BACKGROUND

• Santodomingo-Rubido J, Carracedo G, Suzaki A, Villa-Collar C, Vincent SJ, Wolffsohn JS. Keratoconus: An updated review. Cont Lens Anterior Eye. 2022 Jun;45(3):101559. doi: 10.1016/j.clae.2021.101559. Epub 2022 Jan 4.

  PMID: 34991971 BACKGROUND

MeSH Terms

Conditions

Keratoconus; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)