]>
IRCT20161106030746N2 IRCT 2025-11-02 Karaj University of Medical Sciences The effectiveness of simultaneous pterygium excision and phacoemulsification on visual outcomes in patients A clinical trial comparing the effectiveness of simultaneous pterygium excision and phacoemulsification with separate procedures on visual outcomes in patients with concurrent pterygium and cataract 2025-11-22 anticipated 30 Recruiting https://irct.ir/trial/86989 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be enrolled by one of the research colleagues. A person, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study to be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after the enrolled participants are analyzed. In this study the instructor and participants will not be blinded to the group allocation but care provider and responsible for data collection will be blinded to the group allocation, Blinding description: This study is a single-blind in which both researchers and patients are unaware of the allocation. Upon completion of the study and collection of results, the corresponding codes for each patient will be provided to the specialized team. The single-blind nature of the study was maintained by ensuring that the clinical supervisor and the individual responsible for data collection were not privy to the patients’ allocation. Consequently, the results will be presented anonymously and in a coded format. 2-3 Condition 1: Pterygium. Condition 2: Cataract. Intervention 1: Intervention group: The intervention group 1, Participants will undergo pterygium excision and phacoemulsification in a single operative session. Intervention 2: Intervention group: The intervention group 2, Participants will first undergo pterygium excision, followed by phacoemulsification surgery after a one-month interval. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Nima Rastgar Rad provides the data analysis to the applicants via email: rrnima88@gmail.com How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Nima Rastgar Rad
Alborz University of Medical Sciences, Taleghani Boulevard, Taleghani square, Karaj, Iran
Karaj Iran (Islamic Republic of) 3198764653 +98 21 6692 0178 rrnima88@gmail.com Karaj University of Medical Sciences scientific Nima Rastgar Rad
Alborz University of Medical Sciences, Taleghani Boulevard, Taleghani square, Karaj, Iran
Karaj Iran (Islamic Republic of) 3198764653 +98 21 6692 0178 rrnima88@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 50 years Patients diagnosed with cataracts and pterygium Having full consent to participate in the study 50 years no limit Both Having severe pterygium Having corrected distance visual acuity (CDVA) exceeding 0.15 logMAR Having unreliable refractive measurements History of ocular surgery or traumatic eye injury, or coexisting ocular pathologies other than pterygium and cataract H11.0 H26.9 Pterygium of eye Unspecified cataract Treatment - Surgery Treatment - Surgery Intervention group: The intervention group 1, Participants will undergo pterygium excision and phacoemulsification in a single operative session. Intervention group: The intervention group 2, Participants will first undergo pterygium excision, followed by phacoemulsification surgery after a one-month interval. Corrected visual acuity. Timepoint: Before, 1, 2, and 3 months after intervention. Method of measurement: Snellen chart. Astigmatism. Timepoint: Before, 1, 2, and 3 months after intervention. Method of measurement: Refraction test. Keratometry. Timepoint: Before, 1, 2, and 3 months after intervention. Method of measurement: Keratometer device. Karaj University of Medical Sciences Approved 2025-07-15 Ethics committee of Alborz University of Medical Sciences Office of the Ethics Committee, Second Floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)