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Clinical Trial Summary

Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.


Clinical Trial Description

Subjects were fitted with ortho-k lenses of conventional (0.75 D) and increased (1.75 D) compression factor. The laterality of the compression factor for each subject was randomised.

Subjects were instructed and trained with proper lens handling and disinfection procedures. Lenses were given to the subjects only when they demonstrated proper techniques.

All subjects were required to attend regular follow-ups (baseline, first overnight, and weekly over one-month period). The follow-ups were scheduled (except for the first overnight which was scheduled in the early morning) at a similar time to the baseline visit (+/- 2 hours) to minimise any potential influence of diurnal variation on ocular biometrics.

Additional unscheduled visits were provided when necessary to ensure good ocular health and vision throughout the study period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02643875
Study type Interventional
Source The Hong Kong Polytechnic University
Contact
Status Completed
Phase N/A
Start date February 26, 2016
Completion date November 18, 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04295707 - Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers N/A
Completed NCT02643342 - A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye N/A
Active, not recruiting NCT04293328 - Monthly Replacement Orthokeratology for Myopia Control in Young Children N/A
Recruiting NCT05192824 - Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality N/A