Optical Defocus to Stimulate Eye Elongation in Hyperopia (ODSEEH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00950924 |
Recruitment Status :
Active, not recruiting
First Posted : August 3, 2009
Last Update Posted : January 12, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperopia Refractive Error | Device: Simultaneous Vision Bifocal Soft Contact Lenses Device: Single Vision Soft Contact Lenses | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Use of Multifocal Contact Lenses to Stimulate Axial Elongation in Axial Hyperopia |
Study Start Date : | January 2015 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | January 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Bifocal Contact Lenses
Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.
|
Device: Simultaneous Vision Bifocal Soft Contact Lenses
Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power. |
Placebo Comparator: Single Vision Soft Contact Lenses
Subjects will be fitted with single vision soft contact lenses with goal of corrected emmetropia at a distance of 20 feet.
|
Device: Single Vision Soft Contact Lenses
Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction. |
- Axial length [ Time Frame: One year ]
- Refractive Error [ Time Frame: One year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 5-12
- Hyperopia > +1.25 each eye (cycloplegic refraction)
- Ability to wear soft contact lenses
Exclusion Criteria:
- Amblyopia
- Strabismus
- Astigmatism > 1.00 diopters
- Axial Length > 24.00 mm

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950924
United States, California | |
711 Kains Ave | |
San Bruno, California, United States, 94066 |
Principal Investigator: | Thomas A Aller, O.D. | Unafilliated |
Responsible Party: | Aller, Thomas A., OD |
ClinicalTrials.gov Identifier: | NCT00950924 |
First Posted: | August 3, 2009 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Hyperopia Refractive Error Ocular Biometrics |
Axial Length Contact Lenses Bifocal Contact Lenses |
Refractive Errors Hyperopia Eye Diseases |