Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02722291
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study is aimed at presbyopic patients that do not require magnifying glass at close rage. The purpose of this study is to investigate the functional and physiological changes in eye induced by pinhole glass.

Condition or Disease	Intervention/Treatment	Phase
Pinhole	Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Study Start Date: Mar 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: presbyopia All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with multiple pinhole glasses	Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)

Outcome Measures

Primary Outcome Measures

1. Distant visual acuity (logMAR) [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.

2. BUT [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   fluorescein is instilled into the subject's tear film and the subject is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination

3. Near point of accommodation (NPA) [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Near point of accommodation (NPA) was measured using Donder's push-up method.

4. The fusional convergence [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   With the subject watching the 20/30 sized fixation target at 40 cm, we take the base-out bar prism on the subject's right eye. While gradually increasing the extent of the prism, the first point that the subject noticed diplopia was defined as the break point.

5. Stereopsis [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).

6. Reading speed (letters per second) [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Reading speed was evaluated using the famous Korean traditional fairy tale book. This Korean book was printed black-and-white with 10-font size.

7. Photopic pupil size (baseline, mm) [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Pupil size under photopic conditions (85 cd/m2) was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).

8. Pupil size with the one eye pinhole glasses (mm) [Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study]

   Pupil size with the one eye pinhole glasses was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. age over 45 years

2. spherical equivalents(SE) within ± 3.0 diopters(D)

3. normal ocular alignment

Exclusion Criteria:

1. disturbance of accommodation due to any reasons such as an Adie's pupil, Parkinson's disease, a history of previous ocular surgery or trauma, and a history of systemic or topical medication that might affect accommodation

2. corneal pathologic features

3. glaucoma

4. cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III)

5. vitreous and retinal abnormalities that might limit the accuracy of testing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang University Hospital	Seoul		Korea, Republic of	156-755

Sponsors and Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Hyun Park, Principal investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• ClinicalTrials.gov Identifier: NCT02722291
• Other Study ID Numbers: ChungAngUHophthalmology
• First Posted: Mar 30, 2016
• Last Update Posted: Apr 1, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Hong Hyun Park, Principal investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine: presbyopia
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Apr 1, 2016