Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

Myopia Clinical Trial

Official title:

Topography-Guided Customized PRK (Photorefractive Keratectomy) Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291873
• Other study ID #: 900800700600500400300200100900
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures:

topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II).

Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation.

The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 years

• Myopia with up to -6.5 D with or without astigmatism up to -4.75 D

Exclusion Criteria:

• anterior segment abnormalities (ie, cataracts, corneal scarring)

• basement membrane disease

• history of recurrent corneal erosions

• Schirmer's test less than 5 mm

• established or forme fruste keratoconus

• macular or retinal disease

• current use of immunosuppressive therapy

• autoimmune disease

• pregnancy, and lactation

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Procedure:
• PRK
PRK using Alcon-Wavelight Excimer Laser EX 500

Locations

Country	Name	City	State
Egypt	Dar Al Oyun hospital	Giza
Egypt	Eyecare centre	Maadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer		1 , 3 and 6 months postoperative
Primary	change in visual acuity using snellen chart		1 , 3 and 6 months postoperative
Primary	change in corneal wavefront aberrations	assessed by topolyzer	1 , 3 and 6 months postoperative
Primary	change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug	by CSO Sirius scheimpflug	1,3 and 6months
Primary	change in total RMS	by CSO Sirius scheimpflug	1,3 and 6months
Primary	change in strehl ratio	by CSO scheimpflug	1,3 and 6 months
Primary	change in Q value	assessed by topolyzer	1,3 and 6 months
Secondary	efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA	ratio of postoperative decimal UDVA to preoperative decimal CDVA	6 months
Secondary	contrast sensitivity	cambridge low contrast sensitivity	6 months
Secondary	predictability	eyes within 1.0 D of emmetropia	6 months
Secondary	safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA	ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA	6 months
Secondary	stability	change of more than 0.5D over	6 months