Test of the effect of Pulsed Light in the treatment of Dry eye

Not Applicable

• Conditions: D066234; Xerophthalmia; Ophthalmopathy; Lacrimal Apparatus Diseases, Other specified disorders of the eye and appendages; D009885

• Registration Number: RBR-9m3jy47
• Lead Sponsor: Bernardo Reichert

Brief Summary

It is possible to conclude that the improvement of signs and symptoms of dry eye does not depend on Meibomius gland expression, as there was no present difference between the results between the LIPexMG and LIP-only groups. The results of both groups are similar in all aspects.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-14
• Results First Posted: 2021-02-02
• Study Start: 2021-06-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

To be literate (to be able to read and sign the informed consent form); to be of legal age; to be able to follow the treatment schedule and to follow their requirements; to have a BUT equal to or less than 7.

Exclusion Criteria

Those who did not completed all treatment; they did not want to participate in the study anymore; they had an infection during treatment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The tear osmolarity values of each patient were compared before and after the proposed treatment. Similar results were expected in both of the groups. The IPLexMG group alone had its average osmolarity ranging from 334.6 [318-357] to 330.7 [307-371], demonstrating that after three sessions the osmolarity decreased by an average of 3.9 mOsm. A similar efficacy can be seen when we analyze the patients in the IPL group. This group showed an improvement of 337.5 [303-376] to 323.2 [307-341], a decrease of 14.3 mOsm. The comparison between both groups showed no significant difference (p equal to 0.496). This demonstrate the primary outcome.;As a primary outcome, there was an improvement in the BUT values, from mean 3.4 [0-7] to 6.3 [2-11] in the IPL/MGX group and from 3.7 [2-5] to 6.3 [4 -10] in the IPL group (p equal to 0.0064 and 0.025 respectively). The comparison between the groups showed no statistical significance between the two proposed treatments (p equal to 0.955).<br>

Secondary Outcome Measures

Name	Time	Method
When analyzed the values of the Schirmer test the same can be noticed. Improvement of the mean in the IPLexMG treatment from 9.7 [2-25] to 13.1 [0-35] (p equal to 0.291) and in the IPL treatment from 12.1 [4-30] to 17.1 [4-30 ] (p equal to 0.139). The two treatments also have similar effectivness (p equal to 0.681). This demonstrate the secondary outcome;Regarding the OSDI questionnaire , it can be noticed a significant drop in its severity score, ranging from 43.2 to 19.4 in the IPLexMG group (p equal to 0.0008) and from 33.5 to 10.45 in the IPL group (p equal to 0.066). There was no statistical significance between both groups (p equal to 0.866). Demonstrating a secondary outcome.